Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes

Not Applicable

Completed

• Conditions: Obesity; Diabetes Mellitus, Type 2
• Interventions: Behavioral: Standard lifestyle; Behavioral: Time restricted feeding

• Registration Number: NCT05717127
• Lead Sponsor: Mount Sinai Hospital, Canada

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-02-08
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard lifestyle	Standard lifestyle	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
Intermittent fasting (time restricted feeding)	Time restricted feeding	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).

Primary Outcome Measures

Name	Time	Method
Pancreatic beta-cell function	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 Outcome Measures

Name	Time	Method
Fasting glucose	at week 16	Difference in change in fasting glucose between each intervention period

Trial Locations

Locations (1)

Leadership Sinai Centre foe Diabetes - Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada