ALLEVIATE: Feasibility of Low Energy Diet in HFpEF and Type 2 Diabetes
Study Details
Study Description
Brief Summary
Open, Single arm intervention, feasibility study
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Low energy meal replacement plan 12 weeks |
Dietary Supplement: Low energy meal replacement plan (12 weeks)
Low energy meal replacement plan (12 weeks)
|
Outcome Measures
Primary Outcome Measures
- Recruitment and retention rates [16 weeks]
The number of people approached, recruited and retained
Secondary Outcome Measures
- Differences in 6 minute walk test pre- and post intervention [12 weeks]
Meters walked within 6 minutes
- 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 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 E/A ratio pre- and post intervention [12 weeks]
Standard clinical echocardiography
- Differences in E (cm/s) pre- and post intervention [12 weeks]
Standard clinical echocardiography
- 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 Septal e' pre- and post intervention [12 weeks]
Standard clinical echocardiography
- Differences in Lateral e' pre- and post intervention [12 weeks]
Standard clinical echocardiography
- Differences in Septal E/e' pre- and post intervention [12 weeks]
Standard clinical echocardiography
- Differences in Lateral E/e' 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 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 BMI pre- and post intervention [12 weeks]
Weighing scales and stadiometer measurement (Kg/m2)
- Differences in Bone Mineral Density (g/cm2) pre- and post intervention [12 weeks]
DEXA scan
- Differences in Total Fat mass (g) pre- and post intervention [12 weeks]
DEXA scan
- Differences in Total tissue fat (%) pre- and post intervention [12 weeks]
DEXA scan
- 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 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
- Difference in Medical Research Council Dyspnoea Scale pre- and post intervention [12 weeks]
scale 1 - 5 with lower scores indicating better outcome
- 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 Fasting Glucose (mmol/L) pre- and post intervention [12 weeks]
Biochemistry
- Differences in HbA1c (%) pre- and post intervention [12 weeks]
Biochemistry
- Differences in HbA1c (mmol/mol) pre- and post intervention [12 weeks]
Biochemistry
- Differences in B-type (ng/L) natriuretic peptide pre- and post intervention [12 weeks]
Biochemistry
- Differences in hs-troponin (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 albumin concentration pre- and post intervention [12 weeks]
Biochemistry
- Differences in albumin/creatinine ratio concentration pre- and post intervention [12 weeks]
Biochemistry
- Differences in sodium (mmol/L) pre- and post intervention [12 weeks]
Biochemistry
- Differences in potassium (mmol/L) pre- and post intervention [12 weeks]
Biochemistry
- 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 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 ALP (iu/L)pre- and post intervention [12 weeks]
Biochemistry
- Differences in LDL (mmol/L) pre- and post intervention [12 weeks]
Biochemistry
- Differences in kidney function pre- and post intervention [12 weeks]
Blood analysis for eGFR (ml/min)
- Differences in liver function pre- and post intervention [12 weeks]
Blood analysis for ALP (iu/L)
- 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 (%)
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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))
Exclusion Criteria:
-
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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cardiovascular Research Centre (Glenfield Hospital) | Leicester | Leicestershire | United Kingdom | LE3 9QP |
Sponsors and Collaborators
- University of Leicester
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0699