Feasibility of Low Energy Diet in HFpEF and Type 2 Diabetes

NCT04173117 | Terminated

• 1 other identifier: 0699
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Open, Single arm intervention, feasibility study

Conditions

Dietary Exposure

Outcome Measures

Primary Outcomes (1)

• Recruitment and retention rates

  The number of people approached, recruited and retained

  16 weeks

Secondary Outcomes (47)

• 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

Study Arms (1)

Intervention

EXPERIMENTAL

Low energy meal replacement plan 12 weeks

Dietary Supplement: Low energy meal replacement plan (12 weeks)

Interventions

Low energy meal replacement plan (12 weeks) DIETARY_SUPPLEMENT

Low energy meal replacement plan (12 weeks)

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

Cardiovascular Research Centre (Glenfield Hospital)

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Low energy meal replacement plan for 12 weeks

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 21, 2019
• Study Start: February 28, 2020
• Primary Completion: April 21, 2023
• Study Completion: April 21, 2023
• Last Updated: April 28, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)