| CTRI Number |
CTRI/2020/03/024245 [Registered on: 25/03/2020] Trial Registered Prospectively |
| Last Modified On: |
31/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Protein Intake and Resistance Exercise] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving Sarcopenia among people with diabetes by nutrition and exercise |
|
Scientific Title of Study
|
Study on Effect of Nutritional Intervention and Exercise to Improve Sarcopenia among Type 2 Diabetic Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay Viswanathan |
| Designation |
Head and Chief Diabetologist |
| Affiliation |
M V Hospital for Diabetes and Prof M Viswanathan Diabetes Research centre |
| Address |
4 West Madha Church Street Royapuram
4 West Madha Church Street Royapuram
Chennai
TAMIL NADU
600 013
India |
| Phone |
|
| Fax |
|
| Email |
drvijay@mvdiabetes.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Viswanathan |
| Designation |
Head and Chief Diabetologist |
| Affiliation |
M V Hospital for Diabetes and Prof M Viswanathan Diabetes Research centre |
| Address |
4 West Madha Church Street Royapuram
4 West Madha Church Street Royapuram
Chennai
TAMIL NADU
600 013
India |
| Phone |
|
| Fax |
|
| Email |
drvijay@mvdiabetes.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Viswanathan |
| Designation |
Head and Chief Diabetologist |
| Affiliation |
M V Hospital for Diabetes and Prof M Viswanathan Diabetes Research centre |
| Address |
4 West Madha Church Street Royapuram
4 West Madha Church Street Royapuram
Chennai
TAMIL NADU
600 013
India |
| Phone |
|
| Fax |
|
| Email |
drvijay@mvdiabetes.com |
|
|
Source of Monetary or Material Support
|
| Prof M Viswanathan Diabetes Research Centre |
|
|
Primary Sponsor
|
| Name |
Prof M Viswanathan Diabetes Research Centre |
| Address |
4, West Madha Church Road
Royapuram
Chennai - 600 013 |
| Type of Sponsor |
Research institution |
|
|
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 Vijay Viswanathan |
M V Hospital For Diabetes Pvt Ltd |
4 West Madha Church Street
Royapuram
Chennai - 600 013
Chennai
TAMIL NADU |
914425954913
drvijay@mvdiabetes.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee - Prof. M. Viswanathan Diabetes Research Centre |
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 |
| Comparator Agent |
Control Group |
Standard Care |
| Intervention |
Intervention - diet |
1.2gm protein per kg body weight |
| Intervention |
Intervention - Diet and exercise |
Diet - 1.2gm protein per kg body weight
Exercise - Resistance Exercise |
| Intervention |
Intervention-Exercise |
Resistance Exercise |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
K/C/O T2DM, above 30 years of age, with low muscle mass (lean).
Type 2 diabetes above 30 years of age.
Duration of Diabetes - within 5 years.
People with low muscle mass and low muscle strength.
Patients attending OP clinic of MV hospital for Diabetes, Royapuram will be included (especially those who come from Chennai or nearby district).
Patients who are voluntarily willing to provide Informed consent.
|
|
| ExclusionCriteria |
| Details |
People with normal muscle mass and muscle strength.
People with any cognitive impairment are excluded from exercise intervention group.
People with any Kidney diseases are excluded.
Pregnant and lactating women are excluded.
Patients who are in the insulin treatment and who taking SGLT2 inhibitors are excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in muscle mass
|
6th and 12th months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine and compare the results within the intervention groups. |
12th month |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
30/03/2020 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Sarcopenia
is a condition in which progressive loss of
skeletal muscle and muscle function will be present, especially for older population. Literature shows that there is a greater declines in the leg muscle mass and
strength in T2DM patients compared to those without diabetes. Literature shows that supplementation of selected nutrients such as
protein and Vitamin D enhances the body composition and muscle mass. Also, there
are evidence that physical activity can reduce the loss of skeletal muscle and physical inactivity can worsen the condition. The aim of the study is to see the effect of nutritional intervention and exercise in improving the muscle mass among people with type 2 Diabetes. The patients who are attending the OP of MV hospital for Diabetes, according to the Inclusion & Exclusion criteria, after explaining the study details (Patient Information Sheet) and obtaining the Informed consent (Voluntary involvement) will be screened for Sarcopenia (Grip Strength, Gait Speed and Skeletal Muscle Mass values). The sarcopenia cases will be randomly allocated to the study groups (1 - Protein intake, 2 - Resistance exercise, 3 - Protein intake & resistance exercise, 4 - Control group, The standard care) as per the computer generated randomized numbers. Also, the study participants will be given the appropriate counselling according to the groups allocated. The study participants will be followed up till 6th month and 1 year duration of recruitment. Monthly once, the study participants will be contacted and counselling will be given (Via phone). The same values (Grip Strength, Gait Speed and Skeletal Muscle Mass values) will be assessed during the follow-up and improvement will be measured in each group & compared. |