Diet and exercise in diabetes patients with Sarcopenia

Recruiting

Conditions: Type 2 diabetes mellitus with other specified complications,

Registration Number: CTRI/2022/04/042186

Lead Sponsor: INDIAN COUNCIL OF MEDICAL RESEARCH

Brief Summary: a.    **Background:** Sarcopenia describesdeclines in muscle mass and strength and has been implicated as both a causeand consequence of T2DM. T2DM is characterized by insulin resistance, increasedadvanced glycation end products (AGEs), a proinflammatory phenotype andoxidative stress, which can lead to micro- and macro-vascular complications whichmay lead to losses in skeletal muscle mass, strength, and function, potentiallyleading to the development of dynapenia and sarcopenia

b.    **Novelty:** this is a first intervention which includesdietary and resistant exercise for management of dynapenia/sarcopenia in type 2diabetes subjects on Indian population.

c.     **Objectives:**Tocompare the effect of dietary intervention (DI) with resistance exercise (RE)verses standard diet (SD) and standard exercise (SE) and in other arm effect ofdietary intervention (DI) with standard exercise (SE) verses standard diet (SD)and resistance exercise (SE) on skeletal muscle mass and function and physicalperformance in type 2 diabetes subjects with Dynapenia or sarcopenia. Glycemia,lipids profile, insulin sensitivity and subclinical inflammation, adherence tothe intervention will also be compared in each group.

d.    **Methods:** The study is a 3-armed randomized controlled trialwhere combination of dietary intervention, resistance exercise and standarddiet and standard exercise will be compared. Total 150 subjects will berecruited with 50 subjects in each arm.

***e.*****Expected outcome:** Acombination of dietary intervention along with resistance exercises is likelyto result in improved muscle mass and function in sarcopenic individuals. Thisin turn will be helpful in improving metabolic abnormalities such as insulinresistance, dyslipidemia and dysglycemia.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 150

Inclusion Criteria

ï‚¢Patients age between 18-60yrs.
ï‚¢Patients diagnosed with Type -2 DM.
Along with Sarcopenic ï‚¢Hand grip strength Men <28 kg, Women <18 kg ï‚¢Appendicular skeletal muscle mass/height2: Men<7.0kg/m2, Women <5.4 kg/m2.
ï‚¢SPPBâ‰¤8 (The maximum score on the SPPB is:12) ï‚¢4-minute gait speed <0.8m/s.

Exclusion Criteria

ï‚¢Patient with concomitant severe heart, liver or renal diseases.
ï‚¢Pregnancy and Lactation, and any physical deformity or loss of extremity.
ï‚¢HIV, HbsAg and HCV positive patients.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
muscle strength, muscle mass and muscle function, biochemical parameters, body composition	At baseline 6 weeks and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Anthropometric measures and Biomarkers	Baseline and 12 weeks

Trial Locations

Locations (1): All India Institute of Medical Sciences, New Delhi
🇮🇳
Delhi, DELHI, India
All India Institute of Medical Sciences, New Delhi
🇮🇳Delhi, DELHI, India
Dr Naval Kishore Vikram
Principal investigator
01126593678
navalvikram@gmail.com