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Effect and related mechanism of muscle gaining interventions in elderly type 2 diabetes mellitus patients with sarcopenic obesity

Effect and related mechanism of muscle gaining interventions in elderly type 2 diabetes mellitus patients with sarcopenic obesity

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065362
Enrollment
Unknown
Registered
2022-11-03
Start date
2022-11-07
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus

Interventions

Control group:Diabetic diet
Resistance training group:Diabetic diet combined with resistance training
Resistance training combined with whey protein supplement group:Diabetic diet combined with resistance training and whey protein supplement

Sponsors

Shanghai Jiaotong University School of Medicine, Renji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The diagnosis of diabetes is based on WHO 1999 diagnostic criteria for diabetes, and hemoglobin A1c (HbA1c) measured by standardized testing methods can be used as the supplementary diagnostic criteria for diabetes: Typical diabetes symptoms (polydipsia, polyuria, overeating, unexplained weight loss) plus random blood glucose >= 11.1mmol/L, or fasting blood glucose >= 7.0mmol/L, or oral glucose tolerance test (OGTT) 2-hour blood glucose >= 11.1mmol/L, or HbA1c >= 6.5%; Patients without typical symptoms of diabetes should be reexamined on another day. Type 2 diabetes was diagnosed according to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020); 2. Type 2 diabetes mellitus patients with HbA1c = 25% for male and >= 35% for female.

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes mellitus; Specific types of diabetes due to other causes; 2. Infection: Patients had a history of infection (including respiratory, urinary, digestive or other system infections) within 1 week before enrollment or at the time of enrollment; 3. Cancer; 4. Rheumatic diseases; 5. Liver function injury (six times the upper limit of normal alanine transaminase); 6. Renal insufficiency (creatinine clearance rate 30mg/24h; 7. NYHA >= Grade III; Poor blood pressure control in hypertensive patients; A definite history of coronary heart disease; Unstable arrhythmias; 8. Severe chronic obstructive pulmonary disease; 9. Myasthenia gravis; Dermatomyositis; Duchenne muscular dystrophy; Other neurological, rheumatic or hereditary myopathy; 10. Edema: The body composition analysis report shows that the body moisture content exceeds the upper limit of the standard; 11. Creatine kinase is above the upper limit of normal; 12. Abnormal thyroid function: Confirmed (subclinical) hyperthyroidism or (subclinical) hypothyroidism; 13. Drugs using that affect blood glucose or muscle within 3 months (including glucocorticoids, growth hormones, sex hormones, thyroid hormones, niacin, diazoxide, ß-adrenergic agonists, thiazide diuretics, phenytoin sodium, interferon gamma, etc.); 14. Unable to eat orally; 15. Gastrointestinal malabsorption: such as inflammatory bowel disease, irritable bowel syndrome, gastrointestinal bleeding, chronic diarrhea, etc.; 16. People who have not recovered from sports injuries; People who are unsuitable for sports, such as definite history of cervical or lumbar disc herniation, scoliosis, knee injury, and definite history of osteoarthritis; 17. A history of active drug abuse, including alcohol; 18. A history of diagnosed mental disease; 19. Any conditions that influenced enrollment determined by the researcher.

Design outcomes

Primary

MeasureTime frame
Hemoglobin A1c (HbA1c);

Secondary

MeasureTime frame
Glycated Albumin (GA);Fasting blood glucose;OGTT 2h blood glucose;Insulin resistance index;Gutt index;Weight;Body mass index (BMI);Waist circumference;Hip circumference;Appendicular skeletal muscle mass (ASM);Skeletal muscle mass index (SMI);Body fat mass (BFM);Percent body fat (PBF);Visceral fat area (VFA);Handgrip strength;Five-time sitting-up time;Triglycerides (TG);Total cholesterol (TC);Low density lipoprotein cholesterol (LDL-C);High density lipoprotein cholesterol;Free fatty acid;The score of the Frail Scale;EQ-5D score;Tumor necrosis factor-alpha (TNF-a);Interleukin-1ß (IL-1ß);IL-2;IL-4;IL-5;IL-6;IL-8;IL-10;Growth hormone (GH);Insulin-Like Growth Factor 1 (IGF-1);

Countries

China

Contacts

Public ContactYaomin Hu

Shanghai Jiaotong University School of Medicine, Renji Hospital

amin99@163.com+86 13651617002

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026