| CTRI Number |
CTRI/2026/03/105539 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Process of Care Changes |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To compare effect of intervention, twenty percent calorie restriction vs control of metformin in elderly individuals above sixty five years by seeing change in HbA1c levels after three months |
|
Scientific Title of Study
|
A non – randomized control trial to study the effect of twenty percent calorie restriction vs metformin in elderly individuals above 65 years , with early diabetes. |
| 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 kirti kamwani |
| Designation |
junior resident |
| Affiliation |
AIIMS NEW DELHI |
| Address |
national center for ageing , department of geriatric medicine , room no 622 , AIIMS NEW DELHI , ansari nagar.
New Delhi
DELHI
110029
India |
| Phone |
9769349998 |
| Fax |
|
| Email |
kirtikamwani7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr pramod kumar mehta |
| Designation |
assistant professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
room no 622 , department of geriatric medicine , national center for ageing , AIIMS NEW DELHI , ansari nagar , pin 110029
New Delhi
DELHI
110029
India |
| Phone |
9769349998 |
| Fax |
|
| Email |
pramodataiims.001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr kirti kamwani |
| Designation |
junior resident |
| Affiliation |
AIIMS NEW DELHI |
| Address |
room no 622 , department of geriatric medicine , national center for ageing, AIIMS NEW DELHI , ansari nagar, pin110029
New Delhi
DELHI
110029
India |
| Phone |
9769349998 |
| Fax |
|
| Email |
kirtikamwani7@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All india institute of medical sciences NEW DELHI |
| Address |
all india institue of medical sciences , ansari nagar , new delhi - 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 kirti kamwani |
AIIMS NEW DELHI |
rom 622 , NATIONAL CENTER FOR AGEING , DEPARTMENT OF GERIATRIC MEDICINE , AIIMS NEW DELHI , ANSARI NAGAR , NEW DELHI , 110029
New Delhi
DELHI |
9769349998
kirtikamwani7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
20 % Calorie restriction |
Compare HbA1c levels after three months , in elderly individuals with HbA1c between 6.5% - 7.5% , comparing intervention 20% calorie restriction |
| Comparator Agent |
Metformin |
Compare HbA1c levels after three months, in elderly individuals with HbA1c between 6.5% - 7.5& , comparator metformin |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
recruiting elderly above age of 60yr |
|
| ExclusionCriteria |
| Details |
Severe cognitive impairement
Taking drugs interfering with glucose metabolism ( eg steroids
Exclusion for metformin group :
Patient with end stage renal disease (stage 4 , 5
Chronic liver disease (Child pugh B,C )
Allergy to metformin
Severe gastrointestinal side effects to metformin
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in Hba1c levels |
baseline , 13weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
CHANGE IN HOMA -IR SCORE
CHANGE IN SF -36 SCORE |
3MONTHS |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
21/03/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
a non randomized control trial to compare metformin with 20% calorie restriction , in elderly individuals > = 65yr , MNA SF score > 10 primary outcome to compare change in HbA1c level after three months secondary outcome to compare change in HOMA - IR score and quality of life assessment patient excluded if already taking any other anti diabetic drug , on drug that modify glucose metabolism like steroid if any of the exclusion for metformin met , advanced kidney and renal disease, allergy to metformin or gastrointestinal side effects present to metformin then participants are added to calorie restriction group 2 weekly telephonic calls to confirm adherence to treatment or development of complications 100 sample size , 50 for metformin group and 50 for calorie restriction group
|