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NCT Number: NCT05717127

Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes

One known cause of type 2 diabetes (T2DM) is beta-cell dysfunction, which refers to the inability of the beta-cells of the pancreas to produce enough insulin for the body's needs. Unfortunately, no anti-diabetic medication or lifestyle intervention has been shown to prevent the worsening of beta-cell function over time. Interestingly, however, intermittent fasting (IF) - where no food is consumed over a period of time - has been shown to promote weight loss and improve cardio-metabolic function. In individuals with T2DM, it is also been shown to improve glycemic control (i.e. reduce the sugar levels). While no research has studied whether IF can improve pancreatic beta-cell function, the positive metabolic effects suggest that it could provide some benefit. The current study will evaluate whether IF can improve pancreatic beta-cell function in individuals with early T2DM.

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Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leadership Sinai Centre foe Diabetes - Mount Sinai Hospital

Toronto, Ontario, M5T 3L9, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women with type 2 diabetes mellitus diagnosed within preceding 10 years
  • Age 20-70 years inclusive
  • Body mass index ≥ 25 kg/m2
  • Diabetes treatment consisting of lifestyle only, metformin or dipeptidyl peptidase-4 (DPP-4) inhibitor either as monotherapy or in combination
  • HbA1c value of 5.5 - 9.0% inclusive

Exclusion criteria

  • Current diabetes treatment with insulin, glucagon-like peptide-1 receptor agonists, sodium-glucose co-transporter 2 (SGLT-2) and/or sulfonylureas
  • Involvements in any other clinical study on lifestyle intervention or requiring drug therapy
  • Any history or eating disorder
  • Renal dysfunction as evidenced by estimated glomerular filtration rate <45 mL/min by Modification of Diet in Renal Disease (MDRD) formula
  • Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases >2.5x the upper limit of normal
  • Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
  • Any other factor likely to limit adherence to the study, in the opinion of the investigators

Treatment and study plan

Time restricted feeding

Behavioral

Restricted feeding with 20 hours of fasting and a 4 hour window of feeding (between 4 and 8 PM or between 5 to 9 PM).

Standard lifestyle

Behavioral

Standard lifestyle recommendations

Primary outcomes

  1. Pancreatic beta-cell function

    Time frame: at week 16

    The difference in percentage change in beta-cell function between each intervention period, measured using the Insulin Secretion-Sensitivity Index-2 (ISSI-2)

Secondary outcomes

  1. Fasting glucose

    Time frame: at week 16

    Difference in change in fasting glucose between each intervention period

Other outcomes

  1. BMI

    Time frame: at week 16

    Difference in change in BMI between each intervention period

  2. Waist circumference

    Time frame: at week 16

    Difference in change in waist circumference between each intervention period

  3. Central abdominal fat mass on Dual X-ray Absorptiometry (DEXA)

    Time frame: at week 16

    Difference in change in central abdominal mass between each intervention period

  4. Insulin sensitivity

    Time frame: at week 16

    Difference in insulin sensitivity measured by the Matsuda Index between each intervention period

  5. Satiety

    Time frame: at week 16

    Difference in hunger assessed by Visual Analogue Scales (0 to 10mm with increased values associated with increased hunger) between each intervention period

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2023
Registry last updated
Oct 3, 2025

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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