Improving Sarcopenia among people with diabetes by nutrition and exercise

Not yet recruiting

Conditions: Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2020/03/024245

Lead Sponsor: Prof M Viswanathan Diabetes Research Centre

Brief Summary: Sarcopeniais a condition in which progressive loss ofskeletal muscle and muscle function will be present, especially for older population. Literature shows that there is a greater declines in the leg muscle mass andstrength in T2DM patients compared to those without diabetes. Literature shows that supplementation of selected nutrients such asprotein and Vitamin D enhances the body composition and muscle mass. Also, thereare 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 140

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in muscle mass	6th and 12th months

Secondary Outcome Measures

Name	Time	Method
To determine and compare the results within the intervention groups.	12th month

Trial Locations

Locations (1): M V Hospital For Diabetes Pvt Ltd
🇮🇳
Chennai, TAMIL NADU, India
M V Hospital For Diabetes Pvt Ltd
🇮🇳Chennai, TAMIL NADU, India
Dr Vijay Viswanathan
Principal investigator
914425954913
drvijay@mvdiabetes.com