Feasibility of Low Energy Diet in HFpEF and Type 2 Diabetes
- Conditions
- Dietary Exposure
- Interventions
- Dietary Supplement: Low energy meal replacement plan (12 weeks)
- Registration Number
- NCT04173117
- Lead Sponsor
- University of Leicester
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- Established T2D (HbA1c ≥6.5%, duration >3months)
- Obesity (BMI ≥30 or ≥27 kg/m2 if black/south Asian ethnicity)
- Symptoms limiting exercise capacity in normal daily activities (dyspnoea or fatigue) or an established diagnosis of HF
- Diagnosis of HFpEF in accordance with European Society of Cardiology criteria: LV EF >50% with objective evidence of cardiac structural or functional alterations (LV hypertrophy (≥12mm); LV mass index ≥115g/m2 for males and ≥95g/m2 for females; E/e' ≥13 and a mean e' septal and lateral wall <9 cm/s; left atrial volume index >34mL/m2 or reduced global longitudinal strain (>-18%); elevated levels of natriuretic peptides (B-type natriuretic peptide >35pg/mL and/or NT-pro B-type natriuretic peptide >125pg/mL))
- Unwilling to undertake MRP (low energy diet)
- HBa1c >10%
- Diabetes duration >12 years
- High-dose insulin requirement: either on full basal-bolus insulin regime or insulin requirement >1U/kg/day
- Have been on insulin treatment >10 years
- Current treatment with anti-obesity drugs
- Diagnosed eating disorder or purging
- Weight loss > 5kg in preceding 3 months (unless related to hospitalisation for HF)
- Absolute contraindications to MRI
- Severe renal impairment eGFR<30ml/min/m2
- Myocardial infarction within preceding 6 months
- History of substance abuse
- Cancer undergoing active treatment
- Unable to consent due to lack of mental capacity
- Pregnancy/considering pregnancy
- People unable to perform activities of daily living independently or unable attend for clinical appointments without a carer/attendant
- Unable to read/understand English sufficiently to provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Low energy meal replacement plan (12 weeks) Low energy meal replacement plan 12 weeks
- Primary Outcome Measures
Name Time Method Recruitment and retention rates 16 weeks The number of people approached, recruited and retained
- Secondary Outcome Measures
Name Time Method Differences in albumin concentration pre- and post intervention 12 weeks Biochemistry
Differences in albumin/creatinine ratio concentration pre- and post intervention 12 weeks Biochemistry
Differences in visceral adipose tissue mass (g) pre- and post intervention 12 weeks DEXA scan
Differences in visceral adipose tissue volume (cm3) pre- and post intervention 12 weeks DEXA scan
Differences in cardiopulmonary exercise test (peak VO2) pre- and post intervention 12 weeks exercise test on a static bike using minute by minute ventilatory gas analysis
Differences in E (cm/s) pre- and post intervention 12 weeks Standard clinical echocardiography
Differences in Average E/e' pre- and post intervention 12 weeks Standard clinical echocardiography
Differences in Total lean body mass (g) pre- and post intervention 12 weeks DEXA scan
Difference in World Health Organisation Disability Schedule (WHODAS 2.0) pre- and post intervention 12 weeks Scale 0 - 48 with lower scores indicating better outcome
Differences in HbA1c (mmol/mol) pre- and post intervention 12 weeks Biochemistry
Differences in hs-troponin (ng/L) natriuretic peptide pre- and post intervention 12 weeks Biochemistry
Differences in Lateral E/e' pre- and post intervention 12 weeks Standard clinical echocardiography
Differences in LA volume indexed pre- and post intervention 12 weeks Standard clinical echocardiography
Differences in TR jet velocity (m/s) pre- and post intervention 12 weeks Standard clinical echocardiography
Differences in Bone Mineral Density (g/cm2) pre- and post intervention 12 weeks DEXA scan
Differences in E/A ratio pre- and post intervention 12 weeks Standard clinical echocardiography
Differences in Septal e' pre- and post intervention 12 weeks Standard clinical echocardiography
Differences in BMI pre- and post intervention 12 weeks Weighing scales and stadiometer measurement (Kg/m2)
Difference in Medical Research Council Dyspnoea Scale pre- and post intervention 12 weeks scale 1 - 5 with lower scores indicating better outcome
Differences in LV remodelling (indexed LV mass) pre- and post intervention 12 weeks CMR measures of cardiac geometry
Differences in LV function pre- and post intervention 12 weeks CMR measures of cardiac function
Differences in MV deceleration time (ms) pre- and post intervention 12 weeks Standard clinical echocardiography
Differences in A (cm/s) pre- and post intervention 12 weeks Standard clinical echocardiography
Differences in Lateral e' pre- and post intervention 12 weeks Standard clinical echocardiography
Differences in Total tissue fat (%) pre- and post intervention 12 weeks DEXA scan
Difference in Minnesota Living with heart Failure Questionnaire pre- and post intervention 12 weeks Scale 0 - 105 with lower scores indicating better outcome
Differences in HbA1c (%) pre- and post intervention 12 weeks Biochemistry
Differences in 6 minute walk test pre- and post intervention 12 weeks Meters walked within 6 minutes
Differences in Septal E/e' pre- and post intervention 12 weeks Standard clinical echocardiography
Differences in Total Fat mass (g) pre- and post intervention 12 weeks DEXA scan
Differences in Fasting Glucose (mmol/L) pre- and post intervention 12 weeks Biochemistry
Differences in B-type (ng/L) natriuretic peptide pre- and post intervention 12 weeks Biochemistry
Differences in CRP (mg/L), natriuretic peptide pre- and post intervention 12 weeks Biochemistry
Differences in potassium (mmol/L) pre- and post intervention 12 weeks Biochemistry
Differences in eGFR (ml/min) pre- and post intervention 12 weeks Biochemistry
Differences in hsTnl(ng/L) pre- and post intervention 12 weeks Biochemistry
Differences in hALT (iu/L) pre- and post intervention 12 weeks Biochemistry
Differences in LDL (mmol/L) pre- and post intervention 12 weeks Biochemistry
Differences in liver function pre- and post intervention 12 weeks Blood analysis for ALP (iu/L)
Differences in kidney function pre- and post intervention 12 weeks Blood analysis for eGFR (ml/min)
Differences in Urea (mmol/L) pre- and post intervention 12 weeks Biochemistry
Differences in creatinine (umol/L) pre- and post intervention 12 weeks Biochemistry
Differences in ALP (iu/L)pre- and post intervention 12 weeks Biochemistry
Differences in sodium (mmol/L) pre- and post intervention 12 weeks Biochemistry
The number of participants who experience any Major Adverse Cardiovascular Events (MACE) 12 weeks At any point during the study if a participant experiences a major cardiovascular event this will be recorded and reported to sponsor in line with handling serious adverse events
Differences in the levels of physical activity pre- and post intervention 12 weeks Objectively measured with an accelerometer
Cardiac rehabilitation uptake 12 months The proportion of participants who were offered and attended cardiac rehabilitation following completion of the intervention (%)
Trial Locations
- Locations (1)
Cardiovascular Research Centre (Glenfield Hospital)
🇬🇧Leicester, Leicestershire, United Kingdom