Feasibility of Prediabetes Remission in Adults With Coronary Heart Disease

NCT05459987 | Completed

• 1 other identifier: ICM 2022-3005
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the feasibility of a 6-month multidisciplinary program to reverse prediabetes in adults with coronary heart disease using the Mediterranean diet, intermittent fasting and exercise.

Conditions

Prediabetic State; Coronary Heart Disease; Healthy Lifestyle; Remission

Outcome Measures

Primary Outcomes (2)

• Feasibility of an intensive multidisciplinary program based on lifestyle changes in coronary heart disease patients recently diagnosed with prediabetes that are referred to the Centre EPIC.

  Total recruitment, recruitment rate, compliance and completion rate at 3 months after the start of the intervention

  at 3 months after the start of the intervention

• Feasibility of an intensive multidisciplinary program based on lifestyle changes in coronary heart disease patients recently diagnosed with prediabetes that are referred to the Centre EPIC.

  Total recruitment, recruitment rate, compliance and completion rate at 6 months after the start of the intervention

  at 6 months after the start of the intervention

Secondary Outcomes (2)

• Proportion of prediabetic participants (HbA1c ≥ 5.7% to 6.4% at the start of the program) in complete remission of prediabetes.

  at 3 and 6 months of the start of the intervention

• Evolution of the HOMA-IR between the start of the program, the end of intervention (3 months) and the follow-up visit (6 months).

  at 3 and 6 months of the start of the intervention

Study Arms (1)

Intervention

EXPERIMENTAL

Behavioral: Lifestyle changes Nutritional advice to progressively integrate a moderate-carbohydrate Mediterranean diet with intermittent fasting 16:8 (5 times/week for 12 weeks). Personalized exercise prescription and training (3 times per week) Personalized education and motivational interviewing

Behavioral: Lifestyle changes

Interventions

Lifestyle changes BEHAVIORAL

Nutritional advice to progressively integrate a moderate-carbohydrate Mediterranean diet with intermittent fasting 16:8 (5 times/week for 12 weeks). Personalized exercise prescription and training (3 times per week) Personalized education and motivational interviewing

Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Coronary heart disease patients referred from the Montreal Heart Institute.
• Aged ≥ 40 years.
• Recently diagnosed prediabetes (HbA1c ≥ 5.7% to 6.4%) in the last 6 months.
• Referred to Centre EPIC because of stable angina, acute coronary syndrome (with or without ST elevation), after coronary revascularization (primary or elective) or bypass surgery.
• Able to perform a maximal exercise test and exercise training program in accordance with current cardiovascular rehabilitation recommendations.
• Able to use a smartphone application or to complete an adherence/compliance diary.
• Able to read, understand and sign the information and consent form.

You may not qualify if:

• Absolute and relative contraindication to exercise testing and/or physical training.
• Diabetic patients (HbA1c ≥ 6.5%) or patients with a HbA1c value of ≥ 5.7% to 6.4% but with the help of oral hypoglycemic agents.
• Taking psychotropic medications that may induce mass gain (tricyclic antidepressants, mirtazapine, paroxetine, lithium, valproate, clozapine, olanzapine) or other medications known to promote mass gain (cortisone).
• Taking recently introduced weight-loss medications (semaglutide).
• Unintentional mass loss of more than 10 kg in the past year.
• Pregnant or nursing women.

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (1)

Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute

Montreal, Quebec, H1T1N6, Canada

Location

Related Publications (7)

• Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.

  PMID: 31518657 BACKGROUND

• Bommer C, Sagalova V, Heesemann E, Manne-Goehler J, Atun R, Barnighausen T, Davies J, Vollmer S. Global Economic Burden of Diabetes in Adults: Projections From 2015 to 2030. Diabetes Care. 2018 May;41(5):963-970. doi: 10.2337/dc17-1962. Epub 2018 Feb 23.

  PMID: 29475843 BACKGROUND

• Hall KD, Ayuketah A, Brychta R, Cai H, Cassimatis T, Chen KY, Chung ST, Costa E, Courville A, Darcey V, Fletcher LA, Forde CG, Gharib AM, Guo J, Howard R, Joseph PV, McGehee S, Ouwerkerk R, Raisinger K, Rozga I, Stagliano M, Walter M, Walter PJ, Yang S, Zhou M. Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake. Cell Metab. 2019 Jul 2;30(1):67-77.e3. doi: 10.1016/j.cmet.2019.05.008. Epub 2019 May 16.

  PMID: 31105044 BACKGROUND

• Dal Canto E, Ceriello A, Ryden L, Ferrini M, Hansen TB, Schnell O, Standl E, Beulens JW. Diabetes as a cardiovascular risk factor: An overview of global trends of macro and micro vascular complications. Eur J Prev Cardiol. 2019 Dec;26(2_suppl):25-32. doi: 10.1177/2047487319878371. Epub 2019 Nov 13.

  PMID: 31722562 BACKGROUND

• Lotta LA, Gulati P, Day FR, Payne F, Ongen H, van de Bunt M, Gaulton KJ, Eicher JD, Sharp SJ, Luan J, De Lucia Rolfe E, Stewart ID, Wheeler E, Willems SM, Adams C, Yaghootkar H; EPIC-InterAct Consortium; Cambridge FPLD1 Consortium; Forouhi NG, Khaw KT, Johnson AD, Semple RK, Frayling T, Perry JR, Dermitzakis E, McCarthy MI, Barroso I, Wareham NJ, Savage DB, Langenberg C, O'Rahilly S, Scott RA. Integrative genomic analysis implicates limited peripheral adipose storage capacity in the pathogenesis of human insulin resistance. Nat Genet. 2017 Jan;49(1):17-26. doi: 10.1038/ng.3714. Epub 2016 Nov 14.

  PMID: 27841877 BACKGROUND

• Iglesies-Grau J, Dionne V, Latour E, Gayda M, Besnier F, Gagnon D, Debray A, Gagnon C, Tessier AJ, Paradis A, Klai C, Martin N, Pelletier V, Simard F, Nigam A, L'Allier PL, Juneau M, Bouabdallaoui N, Bherer L. Cardiac Rehabilitation for Prediabetes and Metabolic Syndrome Remission: Impact of Ultraprocessed Food-Intake Reduction and Time-Restricted Eating in the DIABEPIC-1 Study. CJC Open. 2024 Aug 10;6(11):1411-1421. doi: 10.1016/j.cjco.2024.07.018. eCollection 2024 Nov.

  PMID: 39582705 DERIVED

• Iglesies-Grau J, Dionne V, Latour E, Gayda M, Besnier F, Gagnon D, Debray A, Gagnon C, Pelletier V, Nigam A, L'Allier PL, Juneau M, Bouabdallaoui N, Bherer L. Mediterranean diet and time-restricted eating as a cardiac rehabilitation approach for patients with coronary heart disease and pre-diabetes: the DIABEPIC-1 protocol of a feasibility trial. BMJ Open. 2023 Oct 17;13(10):e073763. doi: 10.1136/bmjopen-2023-073763.

  PMID: 37848307 DERIVED

MeSH Terms

Conditions

Prediabetic State; Coronary Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Louis Bherer, PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Centre EPIC research lab

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 15, 2022
• Study Start: March 15, 2022
• Primary Completion: March 15, 2023
• Study Completion: June 15, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: One year after completion of the study
• Access Criteria: Upon request to the principal investigator

Locations

CA (1)