Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes

NCT05717127 | Completed

• 1 other identifier: 19-0299-A
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2; Obesity

Outcome Measures

Primary Outcomes (1)

• Pancreatic beta-cell function

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

  at week 16

Secondary Outcomes (1)

• Fasting glucose

  at week 16

Other Outcomes (5)

• BMI

  at week 16

• Waist circumference

  at week 16

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

  at week 16

Study Arms (2)

Intermittent fasting (time restricted feeding)

EXPERIMENTAL

Intermittent fasting (IF) study arm consisting of time 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).

Behavioral: Time restricted feeding

Standard lifestyle

ACTIVE COMPARATOR

Standard lifestyle recommendation as per the Diabetes Canada guidelines, where participants are encouraged to maintain regularity in timing and spacing of means with no specific recommendations regarding the hours of fasting

Behavioral: Standard lifestyle

Interventions

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).

Intermittent fasting (time restricted feeding)

Standard lifestyle BEHAVIORAL

Standard lifestyle recommendations

Standard lifestyle

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Leadership Sinai Centre foe Diabetes - Mount Sinai Hospital

Toronto, Ontario, M5T 3L9, Canada

Location

Related Publications (1)

• Kramer CK, Zinman B, Feig DS, Retnakaran R. Effect of Time-Restricted Eating on beta-Cell Function in Adults With Type 2 Diabetes. J Clin Endocrinol Metab. 2025 May 19;110(6):e2045-e2053. doi: 10.1210/clinem/dgae594.

  PMID: 39193706 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Endocrinologist and Clinician-scientist

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 8, 2023
• Study Start: September 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 3, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)