Feasibility of Low Energy Diet in HFpEF and Type 2 Diabetes

  • STATUS
    Recruiting
  • days left to enroll
    4
  • participants needed
    20
  • sponsor
    University of Leicester
Updated on 11 May 2021

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:

  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.
  10. 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.
  11. 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 IdentifierNCT04173117
SponsorUniversity of Leicester
Last Modified on11 May 2021

Eligibility

Yes No Not Sure

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
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
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