Combining exercise with a high-protein low-energy diet to minimise muscle losses during weight loss

Not Applicable

• Conditions: Type 2 diabetes and obesity; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN11175684
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-19
• Last Update Posted: 5 February 2024
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. South Asian ethnicity (Self-declared ethnicity of self)
2. Men and women
3. Aged =40 and =65 years,
4. A clinically coded diagnosis of type 2 diabetes between 3 months and 10 years previously
5. HbA1c 6.5% (48 mmol/mol) to 10% (86 mmol/mol) if not taking glucose-lowering medication; 6% (42 mmol/mol) to 10% (86 mmol/mol) if taking glucose-lowering medication
6. Body Mass Index =27.5 and =45 kg/m2
7. Self-reported stable weight over the previous 6 months (<+/-5% of bodyweight)
8. Treatment stable; no significant change to glucose-lowering regimen in the preceding 3 months, as determined by a study investigator
9. Able to provide informed consent
10. Able to understand written and spoken English or willing to use the University Hospitals of Leicester professional interpreter service
11. Able to take part in structured exercise training requiring the lower limbs (e.g., able to walk without assists or impairment)
12. Willingness and availability to participate in the proposed interventions to which they may be assigned, including attendance of intervention visits such as exercise sessions and adoption of Low Energy Diet which requires abstinence from alcohol
13. Willingness to self-monitor glucose, blood pressure and weight

Exclusion Criteria

1. Individuals with type 1, gestational or monogenic diabetes mellitus
2. On insulin therapy (NOTE: No COMBINE participant will be on insulin at baseline as this is an exclusion criterion. An exception may made for women who are on insulin because of its lack of teratogenic effects rather than because of the inability to control glycaemia on oral agents alone)
3. Drugs or conditions thought by the investigators to have a significant impact on the study protocol or outcomes
4. Serum alanine transaminase level >2.5-fold above the upper limit of the reference range
5. eGFR <45 ml.min-1 per 1.73m2
6. Currently participating in a weight reduction program in addition to routine care
7. Previous bariatric surgery
8. Currently on oral or injected steroids
9. Currently on weight loss medications (not including glucose-lowering medication)
10. Conditions that could impact weight (i.e., active malignancy/treatment in the past year, pregnancy, lactation, planning to become pregnant in the next 8 months)
11. Individuals with a self-reported or diagnosed eating disorder
12. Self-reported milk protein allergy or other allergy or dietary practice that prohibits the use of meal replacement products
13. Previous myocardial infarction, stroke, amputation secondary to type 2 diabetes/peripheral vascular disease, or admission due to cardiovascular disease-related event within 12 months
14. Previous clinically diagnosed atrial fibrillation
15. Previous clinically diagnosed heart failure
16. Pacemaker or implantable cardioverter defibrillator (ICD)
17. Substance abuse. The requirement for alcohol abstinence during the initial 12 weeks will make it unlikely that individuals with alcohol dependence will enrol. Substance abuse will be queried.
18. Presenting with cardiac abnormalities during the exercise electrocardiogram test (inclusive of very high blood pressure)
19. Currently receiving or requiring active treatment for retinopathy.
20. Current participation in another research study with investigational medical product
21. Severe Intolerance or unwillingness/inability to undertake Mixed Meal Tolerance Test (Severity of intolerance to be assessed by a member of the research team during screening visit)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in the change of Lean Body Mass between groups measured using Dual-Energy X-ray Absorptiometry at baseline and 12 weeks