NCT04173117

Feasibility of Low Energy Diet in HFpEF and Type 2 Diabetes

A Low-energy Meal Replacement Plan for Heart Failure With Preserved Ejection Fraction and Type 2 Diabetes: A Feasibility Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Leicester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open, Single arm intervention, feasibility study

Detailed description

The aims of the proposed feasibility study are to assess whether a low-energy meal replacement plan (MRP) in patients with HFpEF and T2D: 1\. Is acceptable to an older, co-morbid, multi-ethnic population The secondary objectives are to assess whether a low-energy MRP in patients with HFpEF and T2D may be: 1. associated with improved symptoms 2. likely to lead to favourable cardiovascular reverse remodelling 3. likely to improve functional capacity and quality of life 4. associated with favourable reductions in cardiovascular biomarkers 5. associated with increased physical activity 6. associated with favourable cardiovascular outcomes All patients will undergo the following assessments at baseline, 12-weeks and 12 months (following MRP): 1. Anthropometry: height, weight, BMI. 2. Haemodynamics: resting heart rate and blood pressure. 3. 6-minute walk test +/- cardiopulmonary exercise test (if able to perform) 4. CMR: contrast enhanced, stress perfusion CMR 5. MLWHFQ 6. WHODAS 2.0 (12-item version) 7. Fasting blood test: full blood count, urea and electrolytes, HbA1c, fasting glucose, BNP, high-sensitivity troponin I, insulin and C-peptide. Plasma (≈35mL) will be stored for future biomarker analysis including metabolomics. 8. Urinalysis for proteinuria and urine protein/creatinine ratio. 9. Body composition; dual-energy X-ray absorptiometry (DEXA) scanning. 12\. At the end of the 12-week intervention, participants will be invited to a semi-structured interview to explore qualitative aspects of the study to guide future trial design. 13\. At 12 months attendance at cardiac rehabilitation will be reviewed. The MRP provided by Cambridge Weight Plan® contains \~810 kcal/day (30% protein, 50% carbohydrate, 20% fat). The diet will be stopped, and a maintenance diet re-introduced once 50% excess body weight has been lost, or by 12 weeks, whichever comes first.

Conditions

• Dietary Exposure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Low energy meal replacement plan (12 weeks)	Low energy meal replacement plan (12 weeks)

Timeline

• Start date: 2020-02-28
• Primary completion: 2023-04-21
• Completion: 2023-04-21
• First posted: 2019-11-21
• Last updated: 2023-04-28

Locations

1 site across 1 country: United Kingdom