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

To evaluate the feasibility of a 6-month multidisciplinary program to reverse type 2 diabetes using the Mediterranean diet, intermittent fasting and exercise.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1T 1N6
      • EPIC Center of the Montreal Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mediterranean diet and Personalized training; 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	Behavioral: Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting; Multidisciplinary program will provide the teaching and supervision necessary to integrate the new knowledge and commitment to these lifestyle changes.
Active Comparator: Intermittent Fasting Intervention; 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)	Behavioral: Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting; Multidisciplinary program will provide the teaching and supervision necessary to integrate the new knowledge and commitment to these lifestyle changes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	at 6 months after the start of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	at 3 and 6 months of the start of the intervention

Collaborators and Investigators

• Sponsor: Montreal Heart Institute

Publications and helpful links

Helpful Links

• 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.
• 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.
• 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
• 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
• 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

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Actual): March 21, 2023
• Study Completion (Actual): May 21, 2023

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Mediterranean Diet, Intermittent Fasting, Training, Lifestyle Changes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: ICM 2022-3018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No