| CTRI Number |
CTRI/2013/06/003787 [Registered on: 27/06/2013] Trial Registered Retrospectively |
| Last Modified On: |
24/06/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effects of anti diabetic drug Metformin in type 2 diabetes mellitus who are not obese |
|
Scientific Title of Study
|
Prospective study of the metabolic efficacy of Metformin in non-obese patients with type 2 diabetes mellitus |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR EESH BHATIA MD DNB |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Endocrinology
SGPGIMS, Lucknow-226014
Rae Bareli Road,
Lucknow- 226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
05222494382 |
| Fax |
|
| Email |
ebhatia@sgpgi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR EESH BHATIA MD DNB |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Endocrinology
SGPGIMS, Lucknow-226014
Rae Bareli Road,
Lucknow- 226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
05222494382 |
| Fax |
|
| Email |
ebhatia@sgpgi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR RAMESH GOMEZ |
| Designation |
SENIOR RESIDENT DM |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
DEPARTMENT OF ENDOCRINOLOGY
SGPGIMS
LUCKNOW-226014
PG QUARTER NO 102
SGPGIMS
LUCKNOW-226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
800904675 |
| Fax |
|
| Email |
gomez@sgpgi.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh Gomez |
outpatient clinic, SGPGIMS, Lucknow |
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow
UTTAR PRADESH |
8004904675
gomez@sgpgi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee, Sanjay Gandhi Institute Of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
diabetes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tablet Metformin 500 mg per orally twice daily |
Tablet Metformin 500 mg per orally twice daily for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Individuals should have type 2 Diabetes Mellitus
2)Duration of disease less than 5 years
3)Body mass index less than 23 kg per meter square
4)Glycosylated Hemoglobin more than 7%
5)Fasting plasma glucose more than 140 mg/dl
6)Post prandial sugar more than 200 mg/dl |
|
| ExclusionCriteria |
| Details |
1)Age less than 18 years and more than 65 years
2)Duration of Diabetes Mellitus more than 5 years
3)Body mass index more than 23 kg per meter square
4)Glycosylated Hemoglobin less than 7% and more than 10 %
5)Fasting plasma glucose less than 140 and more than 200 mg/dl
6)Post prandial sugar less than 200 mg/dl and more than 300 mg/dl
7)Serum creatinine more than 1.4 mg/dl in females and more than 1.5 mg/dl in males or urine albumin more than 300 mg/ 24 hours
8)Patients with acute or chronic liver disease
9)Patients with secondary cause for diabetes
10)Patients who are on drugs which can affects the glucose homeostasis
11)Pregnant and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in fasting plasma glucose, 2 hour plasma glucose after 75 gm oral glucose glucose and HbA1c |
at baseline and after 3 months of treatment with Metformin |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in fasting serum lipid profile and CRP |
0 and 3 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
| | This study is a open label study to assess the efficacy of Metformin in patients who are diagnosed to have type 2 diabetes mellitus in non obese Indians who have ideal body weight ie, 18 to 23 kg/ m2 . Exclusion criteria Individuals who have renal impairment, s creatinine >1.4 mg/dl in women and 1.5 mg/dl in males, who have liver disease, both chronic and acute, and who have active infection. All individuals more than 65 years also will be excluded. Individuals who are already intolerant to metformin and who requires emergency control of hyperglycemia due to their co morbid condition will also be not included in the study. The enrolled individuals will be put on medical nutrition therapy and advised to maintain regular exercise. The compliance will be checked using food frequency questionnaire. The individuals who fulfill the criteria will have their baseline investigations done, which include- 1) HbA1c 2) Plasma glucose, insulin and C peptides in the fasting state, 30, 60, 90 and 120 minutes of 75 gm glucose intake 3) fasting serum lipid profile, serum creatinine, SGPT and C reactive protein 4) urine microalbumin and a baseline fundus examination to rule out any complications related to diabetes. Dose of metformin in this study After 3 months of lifestyle modification, if the HbA1c is > 7% or Fasting plasma sugars >140 or 2 hr plasma glucose >200 mg/dl , they will be started on Metformin 500 mg twice daily per orally. Primary outcome The changes metformin bring in HbA1c, fasting and post prandial plasma sugars at the completion of 6 months of Metformin therapy will be the primary outcome studied. Secondary outcome The secondary outcome to be studied includes changes in serum fasting lipid profile and CRP. Adverse effects including the weight loss, gastrointestinal problems and anorexia will be recorded. | |