Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05459987
Other study ID # ICM 2022-3005
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2022
Est. completion date June 15, 2023

Study information

Verified date November 2023
Source Montreal Heart Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The proposed study will assess the feasibility of an intensive lifestyle program to reverse newly onset prediabetes (HbA1c ≥ 5.7% to 6.4%) in patients with coronary heart disease that would otherwise start a standard cardiac rehabilitation programme (12 weeks with twice weekly exercise, nutrition, and nursing counselling). The patients will be offered an upgraded 6-month intensive team-based multidisciplinary stepwise program with the goal of remitting prediabetes. The program will consist of a 3-month synchronous nutritional, exercise, and motivational intervention and of a 3-month maintenance and follow-up period. The DIABEPIC prevent 1 study is a single-arm, open-label study aiming to demonstrate the feasibility of an intensive multidisciplinary stepwise intervention in newly diagnosed prediabetic and coronary heart disease patients, ultimately aiming to remit prediabetes. The purpose of this first study is to devise and iteratively improve participant recruitment and adherence strategies for a possible future randomized controlled trial. It also includes as goals: to study the efficacy and adherence of an intensive multicomponent lifestyle intervention, to study the proportion of patients that improve or remit their insulin resistant state, to study the changes in a variety of anthropomorphic, physical, analytic, vascular and test parameters and to better characterize the factors associated with prediabetes remission.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date June 15, 2023
Est. primary completion date March 15, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Intervention

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

Locations

Country Name City State
Canada Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Erratum In: Cell Metab. 2019 Jul 2;30(1):226. Cell Metab. 2020 Oct 6;32(4):690. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Proportion of prediabetic participants (HbA1c = 5.7% to 6.4% at the start of the program) in complete remission of prediabetes. Remission of prediabetes will be defined by the following 3 criteria:
An HbA1c < 5.7% at 3 months of intervention (Metabolic criteria).
Which is maintained at 6 months (Duration criteria).
Without the use of glucose-lowering agents (pharmacological criteria).
Proportion of prediabetic patients that reach an HbA1c < 5.7% at 6 months of intervention will also be studied
at 3 and 6 months of the start of the intervention
Secondary Evolution of the HOMA-IR between the start of the program, the end of intervention (3 months) and the follow-up visit (6 months). HOMA-IR is a marker of insulin resistance at 3 and 6 months of the start of the intervention
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Completed NCT05088291 - Application of a New X-ray Protective Device in Coronary Interventional Therapy
Completed NCT03076801 - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease? N/A
Completed NCT04584645 - A Digital Flu Intervention for People With Cardiovascular Conditions N/A
Not yet recruiting NCT04995159 - Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System N/A
Recruiting NCT02967718 - Innovation Research of Differentiation and Treatment Methods Based on CHD Phlegm and Blood Stasis Syndrome N/A
Completed NCT02888652 - Study on the Registration of Coronary Heart Disease Patients Undergoing PCI
Completed NCT02163044 - The Hellenic Postprandial Lipemia Study (HPLS)
Terminated NCT02045134 - Supplementation With Polyphenol-Rich Foods and Atrial Fibrillation After a Cardiac Surgery N/A
Active, not recruiting NCT02244853 - Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease N/A
Completed NCT02440893 - Understanding the Effect of Metformin on Corus CAD (or ASGES)
Completed NCT01920009 - Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines N/A
Terminated NCT01906957 - Cognition and Exercise Training N/A
Completed NCT02753829 - Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease N/A
Completed NCT01826552 - Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent Phase 4
Recruiting NCT01689688 - Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography N/A
Completed NCT01779401 - Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients N/A
Recruiting NCT01462799 - COR-PRIM: Problem-based Learning (PBL) After Coronary Heart Disease (CHD) - Long-term Evaluation in Primary Care of Self-care N/A
Recruiting NCT01456364 - Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing Phase 4
Completed NCT01428947 - Does Coronary Angiography Cause Cognitive Dysfunction? N/A