Aim
To set up Diabetes Clinics and Infrastructure in various parts
of India, particularly rural India and areas with lower GDP
and improve Diabetes awareness amongst the public and health
personnel in these areas.
Providing high Quality Diabetes care services in your Hospital
The Department of Endocrinology, Diabetes and Metabolism,
CMC, Vellore, Schieffelin Leprosy Research and Training Center
(SLR & TC), Karigiri and have undertaken a project supported
by World Diabetes Foundation (WDF), Danida to help the Christian
institutions develop high quality diabetes care services.
This project will train 100 hospitals across the country and
in 20 community health centers.
Diabetes is increasingly being recognized as a public health
problem in India. India today leads the world with the largest
number of persons affected by diabetes. Its prevalence is
about 3 % in rural areas and around 11 % in urban areas is
recognized as are the complications that go with it. The proper
management of diabetes can significantly reduce complications
in the long term. One of the common complications that frequently
goes unrecognized is loss of sensation in the feet, resulting
in frequent occurrence of ulcers leading to amputations. This
project therefore, aims to strengthen four specific aspects
of diabetes care:
1. Medical Management, dietary counseling, exercise and lifestyle
modification.
2. Patient education and guidance
3. Foot care including use of orthopedic shoe.
4. Setting up integrated diabetes clinics with an emphasis
on the close functioning
of the Diabetes Nurse Educator and
Doctor.
Training of the Doctors and Nurse Educator will be done
by the Department of Endocrinology, Diabetes and Metabolism,
CMC, Vellore coordinated by Dr. Nihal Thomas. The training
in community health education, foot care and orthopedic shoe-making
services will be done by Schieffelin Leprosy Research and
Training Center (SLR & TC), Karigiri, about 20 kms form
Vellore, led by Dr. Abraham Joseph.
Participation in the project for the hospital would make a
significant contribution to mission hospitals in the way their
diabetes patients are treated and managed. It would imply:
- Ability of the institution to provide high quality
care to their diabetic patients.
- Availability of standard guidelines for the management
of Diabetes, along with the checklist based screening programmes.
- Smooth flow of patients (relevant investigations before
seeing the physicians, foot care, diabetes education, dietary
counseling).
- Cost-effective management for both the hospital and
the patient.
- Reduction of complications thereby reducing the costs
of the patients.
- Develop a team for quality diabetes management.
Major Achievements
Projects
Has generated more than 80,000,000 Indian Rupees in grants
in the last 5 years
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1.Principle investigator in a in transplantation
of genetically engineered insulin-producing hepatoma cell
lines. Macrocapsulating these cell lines, and transplanting
them intraperitoneally into nude rats with streptozotocin
induced diabetes mellitus. Analysis of insulin producing
cell viability after rat sacrifice and flow cytometric
analysis, viability staining, and macroscopic analysis
of dissected chambers. (2000)(PI) |
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2. PRIME Study- Pioglitazone in Ramzan
in Muslims and it's Effects.-
The first Prospective Randomised double-blind multicentric
drug trial in Ramzan ever. (PI-
sponsored by USAID-Young investigator award- INCLEN, 2003).
(PI) [PHASE III]
Study completed and published. Grant amount: Rs 2, 42,000/-.
AC.Min.No.: 46-n:6-2003.
Publication: Vide Supra- Int J Diab Developing Countries
2006, 26, 39-45.
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3. ORIGIN Trial- (Site PI) [PHASE III].
2004-2011
The leading site in terms of recruitment and retention
in Asia and Europe.
A Multicentre, international, randomized 2X2, Factorial
design study to evaluate the effects of Lantus (Insulin
glargine) versus standard care, and of omega-3-fatty acids
version placebo, in reducing cardiovascular.
R.C. No.: 5401 20-07-2004. IRB. (EC): 5/30/08/03. AC.Min.No.:100-t.
Grant amount: Rs 1, 03, 86,438/- and advancing.
Publications evolved: Trial still ongoing. 1st Publication:
Am Heart Jr, 2008, 155, 32e1-e6.
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4. WDF (World Diabetes Foundation
Grant) |
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-Prevention and control of Diabetes Mellitus
in Rural and Semiurban India Through an
established Network of Hospitals. 2004-2009 (Co-PI)
A unique project, the first large scale national rural
diabetes education project in India.
One hundred hospitals have been covered and a structured
course, follow up strategy and
book have developed. 700 diabetes nurse educators have
been trained, 300 doctors, 80 foot
care technicians and 20 cobblers from across the country.
24 course sessions (10 days) have
been conducted of for doctors and 21 course sessions for
educators (13 days). 25 hospitals
have been visited and evaluated in detail.
AC.Min.No.60-r: 7-04. Rs 15,000, 000/-.
Publications evolved: Vide Supra J Assoc Phys Ind.2009,
57,305-309.
Practical Guide to Diabetes Mellitus- 4th Edition (Academa
Publishers)
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5. Detemir Trial- Multinational Trial:
2004-2006 (Site PI) [PHASE III]. Study completed. Insulin
Detemir in Type 1 subjects with diabetes. R.C. No. : 5349
Grant Amount: 6,81,890/-.
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6. GRACE Study- Multinational Trial: 2003-2008.
Site PI). [PHASE III]
Glucose Reduction and Atherosclerosis Continuing Evaluation.
R.C. No.: 5401
Grant Amount: Rs 1,100,000/-.
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7. GOLD Study- (Site PI) [PHASE II]. Study completed.
The joint leading site in terms of recruitment in
India and the world.
A double-blind, proof of concept trial of the use of
Pegvisomant to reduce urinary albumin excretion in Type
1 and 2 diabetic patients treated with Angiotensin Convertase
Inhibitors I Angiotensin Receptor blockers, with persistent
albuminuria. R.C. No: 5553,
Ac.Min.No.22-S: 3-05.
Grant Amount: Rs 8, 98,000/-.
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8. Bone Densitometry in patients with insulin
analogues- a prospective study. (International Co-Author
and Co-PI). Papaioannou A, Thomas N, Kanakamani. A Multinational
trial jointly conducted by McMaster University, Hamilton
and Christian Medical College, Vellore. 2005-2007.
Study of fracture and Bone mineral density in ORIGIN trial
participants (Origin-Osteoporosis Sub-study).R.C.Min.
No.: 5595. Grant Amount: Rs1,89,000/-.
Publication: Manuscript on BMD and insulin analogues being
worked out.
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9. Inhaled Insulin study in patients with
obstructive lung disease. Multinational trial. 2005-2007.
(Site PI) [PHASE III].
The leading site in terms of recruitment in India. Study
completed.
H7U-MC-IDAS, A Pivotal Open-Label, Parallel Study to Evaluate
the Safety and Efficacy of Human Insulin Inhalation Powder
(HIIP) Compared To Injectable Insulin Inhalation Powder
(HIIP) Compared to Injectable Insulin in Patients with
Diabetes and COPD or Asthma.
R.C.Min.No.: 5656.
E.C.Min.No.: IRB (EC). AC.Min.No.117-a:12-05
Grant Amount: Rs 1,915,000 /-.
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10. Copenhagen-Vellore University Collaboration
on: Low Birth Weight and the risk of glycaemic disorders
as assessed by glucose-insulin clamp studies, indirect
calorimetry and Hydrogen Nuclear magnetic spectroscopy
and the impact of an intensive 6 week phase of exercise.
2006-2011. (PI)
Study in progress, 120 subjects need to be recruited.
The study involves intensive
collaboration between the Copenhagen University where
several personal from the
department of endocrinology have been trained in Denmark
for technical purposes
including metabolic nurses, radiation physicists and endocrinologists.
The department of endocrinology has linked up with community
health, biochemistry,
and radiodiagnosis to enable this project. The department
of endocrinology has become the
first in the country to perform hyperinsulinemic euglycaemic
clamp studies on a regular
basis. Data has evolved to form a basis for insulin sensitivity
in young Indian males.
A link between lack of energy expenditure through indirect
caloriemetry and actiheart has
been established in the low birth weight individuals.
Normative values for intra and inter
myocellular fat and hepatic fat in Indians has been derived.
R.C. Min.No.: 5879, AC.Min.No. 50-y: 6-06 and AC.Min.No.
2-k: 1-09.
Grant Amount: Rs1, 20, 00,000/-.
Publications: More than 10 publications are to be generated
through this study from
2009-2011.
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11. Oral Insulin Study. Multinational trial
2006-2007. (Site PI) [PHASEII]. 2006-2007.
Study completed. Ac.Min.No.21-b:3-06.
Grant Amount: Rs 1,200,000/-.
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12. STEPS Study: Saxagliptin Study Multinational
trial 2006-2009(Site PI) [PHASE III].
A multicenter, randomized, double-blind, placebo combination,
phase 3 trial to evaluate the efficacy and safety of Saxagliptin
in combination with Thiazolidinedione therapy in subjects
with type 2 diabetes who have inadequate glycaemic control
on Thiazolidinedione therapy alone. R.C. No. 6023 AC.
Min. No.: 39-u: 5-06. Grant Amount: Rs 21,78,490/-
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13. ACCORD Study. Avosentan Study (Endothelin
Antagonist) (Site PI) [PHASE III].
2006-2007. (Study Terminated internationally).
A randomized, double blind, placebo controlled parallel
group study to assess the effect of the endothelin receptor
antagonist avosentan on time to doubling of serum creatinine,
end stage renal disease or death in patients with type
2 diabetes mellitus and diabetic nephropathy. R.C.Min.:5858.
Grant Amount: 78,527/-. |
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14. PPD Study on DPPV-4 antagonists in
patients on Oral Hypoglycaemic agents. (Site PI) [PHASE
III]. 2006-2011.
Protocol No. SYR-322-OLE-12 titled a Long-Term, Open-Label
Extension Study to Investigate the Long-Term Safety of
SYR110322 (SYR-322) in Subjects with Type 2 Diabetes.
R.C. Min. No.: 5890.
E.C.Min.No.: IRB (EC) 28.04.2006.
AC.Min.No. 67-k: 8 -06. Grant Amount: Rs 40, 53,378/-
and advancing.
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15. IINHALE: AeRx: Inhaled Insulin Study
in patients with Type 2 Diabetes Mellitus. (Site PI) [PHASE
III]. 2006-2007.
The leading site for recruitment in India.
Trial ID NN1998-1682. Inhaled pre-prandial human insulin
with the AeRx iDMS plus
Glimeperide versus rosiglitazone plus Glimeperide in type
2 diabetes: a 26-week, open-
Label multicentre, randomized, parallel trial to investigate
efficacy and safety.
R.C. No. 6020 .AC.Min.No: 93-i: 10-06. Grant amount: 8,
60,400/-.
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16. Metabolex: Meglitisen as an add on
therapy for patients with Type 2 diabetes Mellitus.
(Site PI) [PHASE II/III]. 2006-2008.
A phase 2/3, randomized, double blind, placebo and active
comparator controlled, parallel group, multicenter study
to determine the safety and efficacy of Metaglidasen (MBX
102) in the treatment of type 2 diabetes in patients sub
optimally controlled on Insulin
R.C. No: 6022. AC.Min.No. 113-j: 12 – 06. Grant
Amount: Rs 16, 39,130/-
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17. Prospective Study in the Usage of Metformin
versus Glibenclemide in Patients with gestational diabetes
mellitus.2007-2010. Self designed and funded by research
corpus in collaboration with Obstetrics and gynaecology
at CMC, Vellore. |
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18. Reboxetine in the therapy of peripheral
neuropathy in subjects with diabetes. (Site PI) [PHASE
III]. 2006-2010. The leading site for recruitment in the
world. Study terminated due to and increased prevalence
of arrhythmias.
Protocol A6061031. A phase 2B long-term, randomized, open
¿label safety and tolerability trial comparing
(S-S) Reboxetine (PNU-165442G) with routine care in patients
with chronic painful diabetic peripheral neuropathy (DPN).
R.C. No.: 6021,IRB(EC)23/09/2006, AC.Min.No.: 13-g:2-07.
Grant Amount: Rs 13,56,906/-.
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19. IDAZ study for inhaled insulin in Type
2 diabetes with normal pulmonary function. (Site PI) 2007-2009.
The leading site for recruitment in the India.
A phase 3, open label, crossover study to evaluate the
efficacy and safety of Human Insulin Inhalation Powder
(HIPP) compared with once daily Insulin Glargine in Insulin
naïve patients with type 2 diabetes mellitus on oral
agents: Protocol H7U-MC-IDAZ.
R.C. No: 6120 E.C. Min.No. IRB (EC) 26.01.2007
AC.Min.No.29-h: 3-06. Grant Amount: Rs 1,300,000/-.
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20. Polypill study (Site PI and Steering
Committee member) 2007-2008. In conjunction with McMaster
University. Study Complete. Published in Lancet, 2009.
Nihal Thomas was part of the steering committee and writing
committee.
A randomized double-blinded controlled trial of the efficacy
and safety of POLYCAP versus its components in subjects
with at least one additional cardio-vascular risk factor
R.C. No. 6019 AC.Min.No.: 29-g: 3-07. Grant Amount: Rs
2,00,000/-.
Publication: Vide supra in publication section- Was principle
last author in the article
Published in: Lancet 2009. 373(9672):1341-51.
This is a landmark publication which has been widely cited
and is likely to make a major
impact on the management of the metabolic syndrome and
diabetes on an international
basis.
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21. Novartis study on DPPV-4 inhibitor
in addition to metformin. 2007-2009. (Site PI) Study complete.
A multicenter, double-blind, randomized, active controlled
study to compare the effect of 52 weeks treatment with
LAF237 50 mg bid to Gliciazide up to 320 mg daily as Add-on
therapy in patients with type 2 diabetes inadequately
controlled with Metformin monotherapy. R.C.Min.No.: 6152.
IRB (EC) - 11.03.07. AC.Min. No.: 38-u: 4-07
Grant Amount: Rs 10, 27,855/-.
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22. Wyeth Study on DPPV-4 inhibitor in
addition to sulphonylureas or metformin. 2007-2008. (Site
PI). Study terminated following inadequate hypoglycaemic
impact to comparator arm.
Protocol 3180A1-200-WW. A 24-week randomized, double-blind,
placebo-controlled, multicenter study of the safety and
efficacy of PPM-204 in subjects with type 2 diabetes.
R.C. No. 6151 AC.Min.No.: 38 T – 4 / 07. Grant Amount:
Rs 32,76,660/-. |
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23. Soluble Insulin Basal Analogue in the
management of Type 2 diabetes three types of doses versus
glargine. [PHASE II]. 2008-2009. Study Completed.
Largest recruiter in the world. On writing committee for
the publication due in 2010.
A 16 week randomized, open labelled, four armed, treat
to target, parallel-group trial, comparing SIBA-D once
daily, SIBA-E once daily, SIBA-D Monday, Wednesday and
Friday, and Insulin glargine once daily, all in combination
with metformin in subjects with type 2 Diabetes failing
on OAD treatment.
AC.Min.No.: 6424 EC.Min.No.IRB (EC) A2 – 27.2.08,
AC.Min.No.: 1-Q: 01-08.
Grant Amount: Rs 32, 55, 926/-.
Publication: Co-author in the publication being written.
Due for 2010.
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24. ALITITUDE study. Study of Aliskiren
in patient with Diabetes and proteinuria or macrovascular
disease and it’s impact on cardiovascular and all-cause
mortality. [PHASE III]. 2008-2011.
A randomized, double-blind, placebo-controlled, parallel
group study to determine whether, in patients with type
2 diabetes at high risk for cardiovascular and renal events,
Aliskiren, on top of conventional treatment, reduces cardiovascular
and renal morbidity and mortality.
R.C.Min No: 6458. E.C.Min No: IRB-9-16-01-2008, AC.Min.No:
15-J:2-06 .
Grant Amount: Rs 2,000,000/- and advancing. |
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25. Pfizer Investigator Initiated Research
Grant for Immunogenetics of Type 1 Diabetes Mellitus 2008-2009.
January-2008. Grant Amount: Rs 400,000/- . |
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26. A Poverty Alleviation and Diabetes
Prevention and Management Programme, Gadag, North Karnataka.
2008-2009. Funded by the Global Micro-clinic Group. with
additional support staff and site resources. AC. Min.
No.:36-d: 5-08.
Grant Amount: Rs 800,000/-.
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HOPE-3 Study. In collaboration with McMaster
university and St John’s Unit of Clinical
Trials. 2008-2013. (Phase III).
A large simple multi centre, international randomized
placebo-controlled trial, utilizing a 2X2 factorial design
and evaluating cholesterol modification with Rosuvastatin
vs. placebo, blood pressure lowering with candesartan/HCT
vs. placebo on major vascular events.
R.C.Min.No.: 6569.IRB Min. No.: 15-11-06-08. AC.Min.No.
87-D: 10-08.
Grant Amount: Rs 6,48.000.00/-
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Dapagliflozin in the control of type 2
diabetes- a Renal Sodium Glucose Transport
Inhibitor.
2009-2010. (Phase III).
A Multicenter, randomized, double-blind, placebo-controlled,
parallel group, phase 3 trial to evaluate the safety and
efficacy of Dapagliflozin in combination with thiazolidinedione
therapy in subjects with type 2 diabetes who had inadequate
glycemic control on thiazolidinedione therapy alone.
R.C.Min.No. 6665. IRB. Min.No. -1-22-10-2008, AC.Min.No.
16-F: 02-09
Grant Amount: Rs 11, 42,460/-
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29. Metabolex in the control of type 2
diabetes mellitus- a Phase 3 study in comparison with
Pioglitazone. 2009-2010. (Phase III).
A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-
and Active Comparator-Controlled Study to Evaluate The
Safety and Efficacy of MBX-102/JNJ-39659100 in Patients
with Type 2 Diabetes Mellitus with Inadequate Glycemic
Control on Metformin Monotherapy. IRB Min.No. 6717, AC.Min.No.:
16g:2-09.
Grant Amount: Rs 16,00,000/-.
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30. Saxagliptin in the treatment of subjects
with type 2 diabetes on insulin or insulin in combination
with metformin. (Phase III). 2009-2011.
A Multicentre Randomized, Double-Blind, Phase 3b Trial
to Evaluate the Efficacy and
Safety of Saxagliptin Added to Insulin Monotherapy or
to Insulin in Combination with
Metformin in Subjects with Type 2 Diabetes Who Have Inadequate
Glycemic Control on
Insulin Alone or on Insulin in Combination with Metformin.
R.C.Min.No.: 6836. Grant Amount: Rs 21, 35,925/-.
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31.A Multi-Centre, randomized, Double blind
study to evaluate the efficacy and a long term
safety of vildagliptin modified release (MR) as add on
therapy to metformin in patient with
type 2 diabetes. RC.Min.No. 6721, AC.Min.No.43-g:5-09
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Study of prevalence of Diabetes Associated
Antibodies and Specific Haplotypes in
subjects with Gestational Diabetes in South India. 2007
– 2009.
EC.Min.No: IRB (EC) 24.07.2007 dt 10th July 2007.
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Study of Immunogenetics of Type 1 Diabetes
in South India with Karolinska
Instiute,Sweden . 2007-2009
EC.Min.No.: IRB(EC)23.07.2007 dt 10th July 2007. |
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33. Indian Diabetes Educator Project Sponsored
by Project-HOPE. A project instituted to
to train 400 diabetes educators across the country through
a 6 month programme with
3 contacts at CMC, Vellore and a distance education programme
in between.
2009-2011. Grant Amount: Rs 3,000,000/-
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34. PEARL Study: Postmenopausal Evaluation
and Risk-Reduction with Lasofoxifene (PEARL). The protocol
requires recruitment of 7500 postmenopausal women with
osteoporosis with 33 countries participating around the
globe. |
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35. Protocol H4Z-MC-GJAD titled: “Effects
of Arzoxifene on Vertebral Fracture Incidence and on Invasive
Breast Cancer Incidence in Postmenopausal Women with Osteoporosis
or with Low Bone Density” – A double-blind,
randomized, placebo-controlled, Phase 3 study to determine
the efficacy of Arzoxifene 20 mg/day to reduce the incidence
of vertebral fractures and invasive breast cancer incidence
in postmenopausal women with osteoporosis or with low
bone density without Osteoporosis. |
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36. Protocol MK-0822 - Phase III trial
on safety and efficacy of Odanacatib in Osteoporosis –
by Clinigene 2009.
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Nationally
Funded |
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1. Indian Council of Medical Research Grant
for the Winter Symposium-2007 in January-
2007 of 100,000/- INR. For Thomas Paul, Nihal Thomas.
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2. CSIR Grant for the Winter Symposium-2007
in January-2007 of 100,000/- INR.
For Thomas Paul, Nihal Thomas. |
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3. Investigator initiated research Grant
for Senthilvasan, Nihal Thomas, CB Sanjeevi
in March 2008, for the year 2007, for the Immunogenetics
of Type 1 Diabetes.
By the Research Society for the Study in Diabetes (RSSDI).
4,00,000/- INR.
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4. Winter Symposium 2007: Grants Raised:
Rs 22, 10,825/-. |
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5. Distance education in Diabetes Grant
for conducting a 1 year fellowship in diabetes
For 100 hundred doctors across India. 2008-2009: 1,500,000/-
INR.
Publications: Vide Supra- 6 workbook series have been
generated. 6 more are pending.
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6. Comparison of two generic forms of
insulin in subjects with Type 1 diabetes. 2009-2010
(Biocon) (Phase III). A randomized active controlled,
parallel group, multi-centre, two stage,
open label, study comparing safety and immunogenicity
of insugen ® R and Insugen ® N
with Actrapid ® and Insulatard in patients with type
1 diabetes mellitus.
IRB Min.No.: 6835. Grant amount: 15, 30,160/-.
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Training Programme
The Doctors and Diabetes Nurse Educators training programme
continues as before, beginning from inviting them to attend
the programme and ending with a final programme to go and
set-up their Diabetes Clinic to manage Diabetes, create awareness
and to prevent the Diabetes in their localities and the regions
close to them. The major achievement till date is that 94
hospitals have been trained and around half of them are functioning.
544 doctors and 121 Diabetes Nurse Educators have been trained
and are providing their services to the people with diabetes
in their Hospitals and the community.
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| Location
– Makunda , Assam |
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| A hospital located in a remote
part of eastern Assam populated by many tribal people |
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| Location
: Presbyterian Hospital,Durtlang- Mizoram |
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| Location:
Shillong - KJP Hospital, Shillong, Meghalaya |
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Foot
care by Diabetic Nurse |
Diet
Counselling |
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| Location –
Paduva Hospital , Trichur , Kerala |
| Catholic mission Hospital |
| 16 km from Thrissur |
| 50 beds rural Hospital |
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| Feet examination |
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| Location
– Gadag , Karnataka |
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B. Monitoring Visit
We have visited 14 hopitals which have set up diabetes clinics,
ward settings and laboratories in an attempt to achieve the
World Diabetes Foundation norms. Continuing Medical Education
for both the Doctors and Nurses of the Hospital were conducted
during the site monitoring visits focusing on the Diabetes
prevention and management. Following the inspection, meeting
was organized with the WDF trained Diabetes team and the senior
management of the Hospital. The evaluation of the inspection
report was presented to them and suggestions were given for
further improvements. Educational CDs on Diabetes, Practical
guide to DM, Patient Educational CDs and Glucometers were
given.
If you are willing and interested to participate in the Quality
Care Initiative training programme, please do let us know
through mail or phone contact.
The following are the details of the training programme:
Eligibility Criteria:
Personnel |
Qualification |
No
of persons |
| Doctors |
MBBS or MD possessing adequate leadership
qualities |
1 |
| Diabetes Nurse Educator |
Diploma or B.Sc. Nursing with a Leadership
Quality and a sense of flexibility and imagination. |
2 |
| Footcare Technician |
BPT or a Nurse |
1 |
| Orthopedic Shoe maker |
8th or 10th pass |
1 |
For details
Dr. Nihal Thomas
Associate Professor, Department of Endocrinology, Diabetes
and Metabolism
Deputy Medical Superintendent, Christian Medical College Hospital,
Vellore-632004
India.
Email: nihal_thomas@yahoo.com
Ph : 91-416-2282528 / 2282491(work)
91-416-2214780(home) or 416-2282413
98431-11996(Mobile) / Fax No: 91-416-4200844
Email: endowdf@yahoo.com
Ms. Ruth Ruby Murray - 09994746927
Mr. Mohan - 099894250795
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