Feasibility of Low Energy Diet in HFpEF and Type 2 Diabetes

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

Patrocinadores

Patrocinador principal: University of Leicester

Fuente University of Leicester
Resumen breve

Open, Single arm intervention, feasibility study

Descripción detallada

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.

Estado general Recruiting
Fecha de inicio February 28, 2020
Fecha de Terminación December 1, 2021
Fecha de finalización primaria July 1, 2021
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Recruitment and retention rates 16 weeks
Resultado secundario
Medida Periodo de tiempo
Differences in 6 minute walk test pre- and post intervention 12 weeks
Differences in cardiopulmonary exercise test (peak VO2) pre- and post intervention 12 weeks
Differences in LV remodelling (indexed LV mass) pre- and post intervention 12 weeks
Differences in LV function pre- and post intervention 12 weeks
Differences in E/A ratio pre- and post intervention 12 weeks
Differences in E (cm/s) pre- and post intervention 12 weeks
Differences in MV deceleration time (ms) pre- and post intervention 12 weeks
Differences in A (cm/s) pre- and post intervention 12 weeks
Differences in Septal e' pre- and post intervention 12 weeks
Differences in Lateral e' pre- and post intervention 12 weeks
Differences in Septal E/e' pre- and post intervention 12 weeks
Differences in Lateral E/e' pre- and post intervention 12 weeks
Differences in Average E/e' pre- and post intervention 12 weeks
Differences in LA volume indexed pre- and post intervention 12 weeks
Differences in TR jet velocity (m/s) pre- and post intervention 12 weeks
Differences in BMI pre- and post intervention 12 weeks
Differences in Bone Mineral Density (g/cm2) pre- and post intervention 12 weeks
Differences in Total Fat mass (g) pre- and post intervention 12 weeks
Differences in Total tissue fat (%) pre- and post intervention 12 weeks
Differences in visceral adipose tissue mass (g) pre- and post intervention 12 weeks
Differences in visceral adipose tissue volume (cm3) pre- and post intervention 12 weeks
Differences in Total lean body mass (g) pre- and post intervention 12 weeks
Difference in World Health Organisation Disability Schedule (WHODAS 2.0) pre- and post intervention 12 weeks
Difference in Medical Research Council Dyspnoea Scale pre- and post intervention 12 weeks
Difference in Minnesota Living with heart Failure Questionnaire pre- and post intervention 12 weeks
Differences in Fasting Glucose (mmol/L) pre- and post intervention 12 weeks
Differences in HbA1c (%) pre- and post intervention 12 weeks
Differences in HbA1c (mmol/mol) pre- and post intervention 12 weeks
Differences in B-type (ng/L) natriuretic peptide pre- and post intervention 12 weeks
Differences in hs-troponin (ng/L) natriuretic peptide pre- and post intervention 12 weeks
Differences in CRP (mg/L), natriuretic peptide pre- and post intervention 12 weeks
Differences in albumin concentration pre- and post intervention 12 weeks
Differences in albumin/creatinine ratio concentration pre- and post intervention 12 weeks
Differences in sodium (mmol/L) pre- and post intervention 12 weeks
Differences in potassium (mmol/L) pre- and post intervention 12 weeks
Differences in Urea (mmol/L) pre- and post intervention 12 weeks
Differences in creatinine (umol/L) pre- and post intervention 12 weeks
Differences in eGFR (ml/min) pre- and post intervention 12 weeks
Differences in hsTnl(ng/L) pre- and post intervention 12 weeks
Differences in hALT (iu/L) pre- and post intervention 12 weeks
Differences in ALP (iu/L)pre- and post intervention 12 weeks
Differences in LDL (mmol/L) pre- and post intervention 12 weeks
Differences in kidney function pre- and post intervention 12 weeks
Differences in liver function pre- and post intervention 12 weeks
Differences in the levels of physical activity pre- and post intervention 12 weeks
Cardiac rehabilitation uptake 12 months
The number of participants who experience any Major Adverse Cardiovascular Events (MACE) 12 weeks
Inscripción 20
Condición
Intervención

Tipo de intervención: Dietary Supplement

Nombre de intervención: Low energy meal replacement plan (12 weeks)

Descripción: Low energy meal replacement plan (12 weeks)

Etiqueta de grupo de brazo: Intervention

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Contacto general

Apellido: Grace Walters

Teléfono: 01162044723

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Copia de seguridad de contactos: Cardiovascular Research Centre (Glenfield Hospital) Grace Walters, PhD 01162044723 [email protected]
Ubicacion Paises

United Kingdom

Fecha de verificación

January 2020

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Número de brazos 1
Grupo de brazo

Etiqueta: Intervention

Tipo: Experimental

Descripción: Low energy meal replacement plan 12 weeks

Acrónimo ALLEVIATE
Datos del paciente No
Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Descripción del modelo de intervención: Low energy meal replacement plan for 12 weeks

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov