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

NCT05495451 | Completed

• 1 other identifier: ICM 2022-3018
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Mediterranean Diet, Intermittent Fasting, Training, Lifestyle Changes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Proportion of diabetic participants in complete remission of diabetes.

  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).

  at 3 and 6 months of the start of the intervention

Study Arms (2)

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

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)

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

Interventions

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

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

Intermittent Fasting Intervention; Mediterranean diet and Personalized training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (1)

EPIC Center of the Montreal Heart Institute

Montreal, Quebec, H1T 1N6, Canada

Location

Related 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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Intermittent Fasting

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fasting; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The randomisation will be effectuated with the participant number only for the Intermittent Fasting Intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Centre EPIC research lab

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: August 10, 2022
• Study Start: January 21, 2022
• Primary Completion: March 21, 2023
• Study Completion: May 21, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: One year after completion of the study
• Access Criteria: Upon request to the principal investigator

Locations

CA (1)