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Completed

NCT Number: NCT05495451

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

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

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Key information

Conditions

Type 2 Diabetes Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Fasting Feeding Behavior Glucose Metabolism Disorders Intermittent Fasting Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EPIC Center of the Montreal Heart Institute

Montreal, Quebec, H1T 1N6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Proportion of diabetic participants in complete remission of diabetes.

    Time frame: at 3 and 6 months of the start of the intervention

    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

  2. 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

    HOMA-IR is a marker of insulin resistance

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Registry information

Acronym: DIABEPIC2

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 10, 2022
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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