Feasibility of Low Energy Diet in HFpEF and Type 2 Diabetes (ALLEVIATE)
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- STATUS
- Recruiting
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- End date
- Jul 31, 2024
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- participants needed
- 20
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- sponsor
- University of Leicester
Summary
Open, Single arm intervention, feasibility study
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:
- 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:
- associated with improved symptoms
- likely to lead to favourable cardiovascular reverse remodelling
- likely to improve functional capacity and quality of life
- associated with favourable reductions in cardiovascular biomarkers
- associated with increased physical activity
- associated with favourable cardiovascular outcomes
All patients will undergo the following assessments at baseline, 12-weeks and 12 months (following MRP):
- Anthropometry: height, weight, BMI.
- Haemodynamics: resting heart rate and blood pressure.
- 6-minute walk test +/- cardiopulmonary exercise test (if able to perform)
- CMR: contrast enhanced, stress perfusion CMR
- MLWHFQ
- WHODAS 2.0 (12-item version)
- 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.
- Urinalysis for proteinuria and urine protein/creatinine ratio.
- Body composition; dual-energy X-ray absorptiometry (DEXA) scanning.
- 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.
- 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.
Details
| Condition | Dietary Exposure |
|---|---|
| Treatment | Low energy meal replacement plan (12 weeks) |
| Clinical Study Identifier | NCT04173117 |
| Sponsor | University of Leicester |
| Last Modified on | 9 June 2022 |
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