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Feasibility of Low Energy Diet in HFpEF and Type 2 Diabetes (ALLEVIATE)

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ClinicalTrials.gov Identifier: NCT04173117
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
University of Leicester

Brief Summary:
Open, Single arm intervention, feasibility study

Condition or disease Intervention/treatment Phase
Dietary Exposure Dietary Supplement: Low energy meal replacement plan (12 weeks) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Low energy meal replacement plan for 12 weeks
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Low-energy Meal Replacement Plan for Heart Failure With Preserved Ejection Fraction and Type 2 Diabetes: A Feasibility Study
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Recruitment and retention rates [ Time Frame: 16 weeks ]
    The number of people approached, recruited and retained


Secondary Outcome Measures :
  1. Differences in 6 minute walk test pre- and post intervention [ Time Frame: 12 weeks ]
    Meters walked within 6 minutes

  2. Differences in cardiopulmonary exercise test (peak VO2) pre- and post intervention [ Time Frame: 12 weeks ]
    exercise test on a static bike using minute by minute ventilatory gas analysis

  3. Differences in LV remodelling (indexed LV mass) pre- and post intervention [ Time Frame: 12 weeks ]
    CMR measures of cardiac geometry

  4. Differences in LV function pre- and post intervention [ Time Frame: 12 weeks ]
    CMR measures of cardiac function

  5. Differences in E/A ratio pre- and post intervention [ Time Frame: 12 weeks ]
    Standard clinical echocardiography

  6. Differences in E (cm/s) pre- and post intervention [ Time Frame: 12 weeks ]
    Standard clinical echocardiography

  7. Differences in MV deceleration time (ms) pre- and post intervention [ Time Frame: 12 weeks ]
    Standard clinical echocardiography

  8. Differences in A (cm/s) pre- and post intervention [ Time Frame: 12 weeks ]
    Standard clinical echocardiography

  9. Differences in Septal e' pre- and post intervention [ Time Frame: 12 weeks ]
    Standard clinical echocardiography

  10. Differences in Lateral e' pre- and post intervention [ Time Frame: 12 weeks ]
    Standard clinical echocardiography

  11. Differences in Septal E/e' pre- and post intervention [ Time Frame: 12 weeks ]
    Standard clinical echocardiography

  12. Differences in Lateral E/e' pre- and post intervention [ Time Frame: 12 weeks ]
    Standard clinical echocardiography

  13. Differences in Average E/e' pre- and post intervention [ Time Frame: 12 weeks ]
    Standard clinical echocardiography

  14. Differences in LA volume indexed pre- and post intervention [ Time Frame: 12 weeks ]
    Standard clinical echocardiography

  15. Differences in TR jet velocity (m/s) pre- and post intervention [ Time Frame: 12 weeks ]
    Standard clinical echocardiography

  16. Differences in BMI pre- and post intervention [ Time Frame: 12 weeks ]
    Weighing scales and stadiometer measurement (Kg/m2)

  17. Differences in Bone Mineral Density (g/cm2) pre- and post intervention [ Time Frame: 12 weeks ]
    DEXA scan

  18. Differences in Total Fat mass (g) pre- and post intervention [ Time Frame: 12 weeks ]
    DEXA scan

  19. Differences in Total tissue fat (%) pre- and post intervention [ Time Frame: 12 weeks ]
    DEXA scan

  20. Differences in visceral adipose tissue mass (g) pre- and post intervention [ Time Frame: 12 weeks ]
    DEXA scan

  21. Differences in visceral adipose tissue volume (cm3) pre- and post intervention [ Time Frame: 12 weeks ]
    DEXA scan

  22. Differences in Total lean body mass (g) pre- and post intervention [ Time Frame: 12 weeks ]
    DEXA scan

  23. Difference in World Health Organisation Disability Schedule (WHODAS 2.0) pre- and post intervention [ Time Frame: 12 weeks ]
    Scale 0 - 48 with lower scores indicating better outcome

  24. Difference in Medical Research Council Dyspnoea Scale pre- and post intervention [ Time Frame: 12 weeks ]
    scale 1 - 5 with lower scores indicating better outcome

  25. Difference in Minnesota Living with heart Failure Questionnaire pre- and post intervention [ Time Frame: 12 weeks ]
    Scale 0 - 105 with lower scores indicating better outcome

  26. Differences in Fasting Glucose (mmol/L) pre- and post intervention [ Time Frame: 12 weeks ]
    Biochemistry

  27. Differences in HbA1c (%) pre- and post intervention [ Time Frame: 12 weeks ]
    Biochemistry

  28. Differences in HbA1c (mmol/mol) pre- and post intervention [ Time Frame: 12 weeks ]
    Biochemistry

  29. Differences in B-type (ng/L) natriuretic peptide pre- and post intervention [ Time Frame: 12 weeks ]
    Biochemistry

  30. Differences in hs-troponin (ng/L) natriuretic peptide pre- and post intervention [ Time Frame: 12 weeks ]
    Biochemistry

  31. Differences in CRP (mg/L), natriuretic peptide pre- and post intervention [ Time Frame: 12 weeks ]
    Biochemistry

  32. Differences in albumin concentration pre- and post intervention [ Time Frame: 12 weeks ]
    Biochemistry

  33. Differences in albumin/creatinine ratio concentration pre- and post intervention [ Time Frame: 12 weeks ]
    Biochemistry

  34. Differences in sodium (mmol/L) pre- and post intervention [ Time Frame: 12 weeks ]
    Biochemistry

  35. Differences in potassium (mmol/L) pre- and post intervention [ Time Frame: 12 weeks ]
    Biochemistry

  36. Differences in Urea (mmol/L) pre- and post intervention [ Time Frame: 12 weeks ]
    Biochemistry

  37. Differences in creatinine (umol/L) pre- and post intervention [ Time Frame: 12 weeks ]
    Biochemistry

  38. Differences in eGFR (ml/min) pre- and post intervention [ Time Frame: 12 weeks ]
    Biochemistry

  39. Differences in hsTnl(ng/L) pre- and post intervention [ Time Frame: 12 weeks ]
    Biochemistry

  40. Differences in hALT (iu/L) pre- and post intervention [ Time Frame: 12 weeks ]
    Biochemistry

  41. Differences in ALP (iu/L)pre- and post intervention [ Time Frame: 12 weeks ]
    Biochemistry

  42. Differences in LDL (mmol/L) pre- and post intervention [ Time Frame: 12 weeks ]
    Biochemistry

  43. Differences in kidney function pre- and post intervention [ Time Frame: 12 weeks ]
    Blood analysis for eGFR (ml/min)

  44. Differences in liver function pre- and post intervention [ Time Frame: 12 weeks ]
    Blood analysis for ALP (iu/L)

  45. Differences in the levels of physical activity pre- and post intervention [ Time Frame: 12 weeks ]
    Objectively measured with an accelerometer

  46. Cardiac rehabilitation uptake [ Time Frame: 12 months ]
    The proportion of participants who were offered and attended cardiac rehabilitation following completion of the intervention (%)

  47. The number of participants who experience any Major Adverse Cardiovascular Events (MACE) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173117


Contacts
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Contact: Grace Walters 01162044723 gwmw1@leicester.ac.uk
Contact: Emer M Brady 01162044723 emb29@le.acuk

Locations
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United Kingdom
Cardiovascular Research Centre (Glenfield Hospital) Recruiting
Leicester, Leicestershire, United Kingdom, LE3 9QP
Contact: Grace Walters, PhD    01162044723    gwmw1@leicester.ac.uk   
Contact: Emer Brady, PhD    01162044723    emb29@le.ac.uk   
Sponsors and Collaborators
University of Leicester

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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT04173117     History of Changes
Other Study ID Numbers: Version 1
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No