Type 2 DiabetesDIABEPIC2NCT05495451
Feasibility and Impact of an Intensive Team-based Intervention on Type 2 Diabetes Reversal
A study testing Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting in people with Type 2 Diabetes, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
To evaluate the feasibility of a 6-month multidisciplinary program to reverse type 2 diabetes using the Mediterranean diet, intermittent fasting and exercise. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting
- 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
- 21 Jan 2022to 21 May 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Ability to give written consent, to use a smartphone application or complete an adherence/compliance diary, and use a blood glucose and blood pressure machine at home.
Who cannot join
- All types of diabetes other than type 2
- Taking the following glucose-lowering agents: insulin, sulfonylureas
- BMI < 18,5 kg/m2
- Unintentional weight loss of more than 10 kg in the past year
- Moderate to severe retinopathy
- Pregnant or nursing woman
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- Severe organ failure
- Pathologies predisposing to gastrointestinal bleeding, untreated
- Recent cholecystitis (3 months)
- Antibiotic use in the past 3 months, or untreated active infection
- Known impaired nutrient absorption
- Uninvestigated new anemia or Hb < 110 g/100 mL
- Currently following an intermittent or prolonged fasting protocol
- Currently following a specific diet (vegan, celiac/gluten free, ketogenic)
- Active diagnoses of psychiatric or neurological illness not controlled for at least 6 months
- Taking, stopping or adjusting a medication in the last 3 months resulting in an active weight change.
Trial locations and contacts
1 site in 1 country.
Canada1 site
EPIC Center of the Montreal Heart Institute
Montreal, Quebec, H1T 1N6
About this study
To evaluate the feasibility of a 6-month multidisciplinary program to reverse type 2 diabetes using the Mediterranean diet, intermittent fasting and exercise.
Read the detailed description
The morbidities associated with type 2 diabetes (Db2) are major, including cardiovascular and renal complications, but also cognitive impairment. Providing interventions targeting Db2 reversal has shown great potential to improve healthy aging.
A Db2 reversal clinic has been established at the Montreal Heart Institute's ÉPIC Center, with an approach based on the Mediterranean diet and exercise. First-year results showed a 0.6% decrease in Hb1Ac and an average weight loss at 3 months of 4.5 kg in diabetic patients. This improvement was maintained at 6 and 12 months. Although these results are encouraging, the literature in Db2 remission shows that a weight loss of 10 kg is the ideal goal.
Therefore, to offer the possibility of further metabolic improvement at 6 months, three interventions are proposed as additions to the current program: targeting ultra-processed food reduction, motivational coaching and intermittent fasting. The main objective of our pilot study is to determine the feasibility of this improved program in type 2 diabetic patients, aged 18 to 80 years.
- Conditions
- Type 2 Diabetes
- Being tested
- Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting
- Keywords
- Mediterranean Diet, Intermittent Fasting, Training, Lifestyle Changes
- Medical subject headings
- Diabetes Mellitus, Type 2, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fastingBehavioural
Multidisciplinary program will provide the teaching and supervision necessary to integrate the new knowledge and commitment to these lifestyle changes.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean diet and Personalized training | Experimental | 36 participants will participate to the following lifestyle changes for 6 months:
Behavioral: Lifestyle changes Nutritional advice to progressively integrate a moderate-carbohydrate Mediterranean diet.
Personalized exercise prescription and training (3 times per week)
Personalized education and motivational interviewing Receives: Behavioral: Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting |
| Intermittent Fasting Intervention | Active comparator | Between 3 and 6 months, 24 participants (on a total of 36) will progressively integrate intermittent fasting 16:8 (5 times/week for 12 weeks) and 20:4 (2 times/week for 4 weeks) Receives: Behavioral: Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting |
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 patients diagnosed with type 2 diabetes.
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 patients diagnosed with type 2 diabetes.
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 diabetic participants in complete remission of diabetes.
Remission of diabetes will be defined by the following 3 criteria:
- An HbA1c < 6,5% 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 Hb1Ac < 6,5% 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 middle of the intervention (3 months) and the end of the intervention (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 posted10 Aug 2022
- Study start21 Jan 2022
- Primary completion21 Mar 2023
- Study completion21 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 36 participants will be taught to follow the Mediterranean diet (40% carbohydrates) and training 3 times a week (HIIT and weight training) for 3 months. At 3 months, there will be a randomization: 12 participants will continue the same interventions while 24 will add Intermittent Fasting Intervention for 3 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495451
- Sponsor's protocol ID
- ICM 2022-3018
- Acronym
- DIABEPIC2
- Status last verified
- Nov 2023
- First submitted
- 14 Mar 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 the sponsor accepts, we would agree with making individual date available to other researchers
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 Type 2 Diabetes Reversal
- ClinicalTrials.gov ID
- NCT05495451
- Acronym / sponsor ID
- DIABEPIC2 / ICM 2022-3018
- Conditions
- Type 2 Diabetes
- Keywords
- Mediterranean Diet, Intermittent Fasting, Training, Lifestyle Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 21 May 2023 (actual)
- First posted
- 10 Aug 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 type 2 diabetes using the Mediterranean diet, intermittent fasting and exercise.
Detailed description
The morbidities associated with type 2 diabetes (Db2) are major, including cardiovascular and renal complications, but also cognitive impairment. Providing interventions targeting Db2 reversal has shown great potential to improve healthy aging.
A Db2 reversal clinic has been established at the Montreal Heart Institute's ÉPIC Center, with an approach based on the Mediterranean diet and exercise. First-year results showed a 0.6% decrease in Hb1Ac and an average weight loss at 3 months of 4.5 kg in diabetic patients. This improvement was maintained at 6 and 12 months. Although these results are encouraging, the literature in Db2 remission shows that a weight loss of 10 kg is the ideal goal.
Therefore, to offer the possibility of further metabolic improvement at 6 months, three interventions are proposed as additions to the current program: targeting ultra-processed food reduction, motivational coaching and intermittent fasting. The main objective of our pilot study is to determine the feasibility of this improved program in type 2 diabetic patients, aged 18 to 80 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 36 participants will be taught to follow the Mediterranean diet (40% carbohydrates) and training 3 times a week (HIIT and weight training) for 3 months. At 3 months, there will be a randomization: 12 participants will continue the same interventions while 24 will add Intermittent Fasting Intervention for 3 months.
| Arm | Type | Receives |
|---|---|---|
| Mediterranean diet and Personalized training | Experimental | Behavioral: Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting36 participants will participate to the following lifestyle changes for 6 months: Behavioral: Lifestyle changes Nutritional advice to progressively integrate a moderate-carbohydrate Mediterranean diet. Personalized exercise prescription and training (3 times per week) Personalized education and motivational interviewing |
| Intermittent Fasting Intervention | Active comparator | Behavioral: Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fastingBetween 3 and 6 months, 24 participants (on a total of 36) will progressively integrate intermittent fasting 16:8 (5 times/week for 12 weeks) and 20:4 (2 times/week for 4 weeks) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes
- Ability to give written consent, to use a smartphone application or complete an adherence/compliance diary, and use a blood glucose and blood pressure machine at home.
Key exclusion criteria (16 listed)
- All types of diabetes other than type 2
- Taking the following glucose-lowering agents: insulin, sulfonylureas
- BMI < 18,5 kg/m2
- Unintentional weight loss of more than 10 kg in the past year
- Moderate to severe retinopathy
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 |
|---|---|---|
| Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fastingMultidisciplinary program will provide the teaching and supervision necessary to integrate the new knowledge and commitment to these lifestyle changes. | Behavioural | Intermittent Fasting Intervention, Mediterranean diet and Personalized training |
Primary outcome
Feasibility of an intensive multidisciplinary program based on lifestyle changes in patients diagnosed with type 2 diabetes.
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 patients diagnosed with type 2 diabetes.
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 diabetic participants in complete remission of diabetes.
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 middle of the intervention (3 months) and the end of the intervention (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.
- Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, Mccombie L, et al.. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. The Lancet 2018;391:541-51. doi:10.1016/s0140-6736(17)33102-1.Link provided by the sponsor.
- Taylor R, Al-Mrabeh A, Sattar N. Understanding the mechanisms of reversal of type 2 diabetes. Lancet Diabetes Endocrinol. 2019 Sep;7(9):726-736.Link provided by the sponsor.
- Zhyzhneuskaya SV, Al-Mrabeh A, Peters C et al. Time Course of Normalization of Functional β-Cell Capacity in the Diabetes Remission Clinical Trial After Weight Loss in Type 2 Diabetes. Diabetes Care 2020;43:813-2Link provided by the sponsor.
- Kemps H, Kränkel N, Dörr M et al.. Exercise training for patients with type 2 diabetes and cardiovascular disease: What to pursue and how to do it. A Position Paper of the European Association of Preventive CardiologyLink provided by the sponsor.
- de Cabo R, Mattson MP. Effects of Intermittent Fasting on Health, Aging, and Disease. N Engl J Med. 2019 Dec 26;381(26):2541-2551Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. If the sponsor accepts, we would agree with making individual date 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting in people with Type 2 Diabetes, 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 2 inclusion and 16 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 patients diagnosed with type 2 diabetes. (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?
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.