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

Type 2 Diabetes Clinical Trial

— DIABEPIC2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05495451
• Other study ID #: ICM 2022-3018
• Status: Completed
• Phase: N/A
• Start date: January 21, 2022
• Est. completion date: May 21, 2023

Study information

• Verified date: November 2023
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 21, 2023
• Est. primary completion date: March 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Canada	EPIC Center of the Montreal Heart Institute	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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

External Links

•   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
•   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
•   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 ß-Cell Capacity in the Diabetes Remission Clinical Trial After Weight Loss in Type 2 Diabetes. Diabetes Care 2020;43:813-2