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Feasibility of Low Energy Diet in HFpEF and Type 2 Diabetes — ALLEVIATE  

Dietary Exposure Clinical Trial

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

Clinical Trial Summary

Open, Single arm intervention, feasibility study

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04173117
Study type Interventional
Source University of Leicester
Contact
Status Terminated
Phase N/A
Start date February 28, 2020
Completion date April 21, 2023
View Details
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