Prediabetic StateDIABEPIC1NCT05459987
Feasibility of Prediabetes Remission in Adults With Coronary Heart Disease
A study testing Lifestyle changes in people with Prediabetic State and Coronary Heart Disease, run by Montreal Heart Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Prediabetic State, Coronary Heart Disease, Healthy Lifestyle
- What is being tested?
- Lifestyle changes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 15 Mar 2022to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
Montreal, Quebec, H1T1N6
About this study
Official title: Feasibility and Impact of an Intensive Team-based Intervention on Prediabetes Remission in Patients With Coronary Heart Disease
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.
Read the detailed 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.
- Being tested
- Lifestyle changes
- Medical subject headings
- Prediabetic State, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle changesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Lifestyle changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
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
Measured: 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).
HOMA-IR is a marker of insulin resistance
Measured: at 3 and 6 months of the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start15 Mar 2022
- Primary completion15 Mar 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis Bherer, Montreal Heart Institute
- Investigators
- Louis Bherer, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459987
- Sponsor's protocol ID
- ICM 2022-3005
- Acronym
- DIABEPIC1
- Status last verified
- Nov 2023
- First submitted
- 22 Jun 2022
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If sponsor OK, we would agree with making individual data available to other researchers
Publications
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.
PubMed 31518657Bommer 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.
PubMed 29475843Hall 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.
PubMed 31105044Dal 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.
PubMed 31722562Lotta 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.
PubMed 27841877Iglesies-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.
PubMed 39582705Iglesies-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.
PubMed 37848307
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Impact of an Intensive Team-based Intervention on Prediabetes Remission in Patients With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT05459987
- Acronym / sponsor ID
- DIABEPIC1 / ICM 2022-3005
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Lifestyle changesBehavioral: 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle changesNutritional 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 | Behavioural | Intervention |
Primary outcome
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.
Time frame: at 3 months after the start of the intervention
Total recruitment, recruitment rate, compliance and completion rate 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.
Time frame: at 6 months after the start of the intervention
Total recruitment, recruitment rate, compliance and completion rate at 6 months after the start of the intervention
2 secondary outcomes
Proportion of prediabetic participants (HbA1c ≥ 5.7% to 6.4% at the start of the program) in complete remission of prediabetes.
Time frame: 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).
Time frame: at 3 and 6 months of the start of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Background: PubMed 31518657Saeedi 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.
- Background: PubMed 29475843Bommer 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.
- Background: PubMed 31105044Hall 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.
- Background: PubMed 31722562Dal 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.
- Background: PubMed 27841877Lotta 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.
- Derived from this study: PubMed 39582705Iglesies-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.
- Derived from this study: PubMed 37848307Iglesies-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.
- Individual participant dataSharing planned: Yes. If sponsor OK, we would agree with making individual data available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Bherer, PhD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle changes in people with Prediabetic State and Coronary Heart Disease, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: at 3 months after the start of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05459987, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.