Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes

Mount Sinai Hospital, Canada

Status: Completed

Conditions: Obesity; Diabetes Mellitus, Type 2

Treatments: Behavioral: Time restricted feeding; Behavioral: Standard lifestyle

Study type: Interventional

Funder types: Other

Identifiers

NCT05717127

19-0299-A

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Intermittent fasting (time restricted feeding)

Experimental group

Description:

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).

Treatment:

Behavioral: Time restricted feeding

Standard lifestyle

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard lifestyle