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Feasibility and Impact of an Intensive Team-based Intervention on Type 2 Diabetes Reversal (DIABEPIC2)

Primary Purpose

Type 2 Diabetes

Status

Active

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Mediterranean Diet, Intermittent Fasting, Training, Lifestyle Changes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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
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.

Sites / Locations

EPIC Center of the Montreal Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mediterranean diet and Personalized training

Intermittent Fasting Intervention

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT05495451

First Posted

March 14, 2022

Last Updated

August 8, 2022

Sponsor

Montreal Heart Institute

1. Study Identification

Unique Protocol Identification Number

NCT05495451

Brief Title

Feasibility and Impact of an Intensive Team-based Intervention on Type 2 Diabetes Reversal

Acronym

DIABEPIC2

Official Title

Feasibility and Impact of an Intensive Team-based Intervention on Type 2 Diabetes Reversal

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 21, 2022 (Actual)

Primary Completion Date

March 21, 2023 (Anticipated)

Study Completion Date

May 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Montreal Heart Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Mediterranean Diet, Intermittent Fasting, Training, Lifestyle Changes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Outcomes Assessor

Masking Description

The randomisation will be effectuated with the participant number only for the Intermittent Fasting Intervention.

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mediterranean diet and Personalized training

Arm Type

Experimental

Arm Description

Arm Title

Intermittent Fasting Intervention

Arm Type

Active Comparator

Arm Description

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)

Intervention Type

Behavioral

Intervention Name(s)

Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting

Intervention Description

Multidisciplinary program will provide the teaching and supervision necessary to integrate the new knowledge and commitment to these lifestyle changes.

Primary Outcome Measure Information:

Title

Feasibility of an intensive multidisciplinary program based on lifestyle changes in patients diagnosed with type 2 diabetes.

Description

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

Time Frame

at 3 months after the start of the intervention

Title

Feasibility of an intensive multidisciplinary program based on lifestyle changes in patients diagnosed with type 2 diabetes.

Description

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

Time Frame

at 6 months after the start of the intervention

Secondary Outcome Measure Information:

Title

Proportion of diabetic participants in complete remission of diabetes.

Description

Time Frame

at 3 and 6 months of the start of the intervention

Title

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).

Description

HOMA-IR is a marker of insulin resistance

Time Frame

at 3 and 6 months of the start of the intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 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.

Facility Information:

Facility Name

EPIC Center of the Montreal Heart Institute

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H1T 1N6

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

If the sponsor accepts, we would agree with making individual date available to other researchers

IPD Sharing Time Frame

One year after completion of the study

IPD Sharing Access Criteria

Upon request to the principal investigator

Links:

URL

http://pubmed.ncbi.nlm.nih.gov/29221645

Description

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.

URL

http://pubmed.ncbi.nlm.nih.gov/31097391

Description

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.

URL

http://pubmed.ncbi.nlm.nih.gov/32060017

Description

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;43:813-2

URL

http://pubmed.ncbi.nlm.nih.gov/30642190

Description

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 Cardiology

URL

http://pubmed.ncbi.nlm.nih.gov/31881139

Description

de Cabo R, Mattson MP. Effects of Intermittent Fasting on Health, Aging, and Disease. N Engl J Med. 2019 Dec 26;381(26):2541-2551

Learn more about this trial

Feasibility and Impact of an Intensive Team-based Intervention on Type 2 Diabetes Reversal

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