Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes

Mount Sinai Hospital, Canada51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2 Obesity

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: at week 16

Secondary Outcomes

Fasting glucose

Difference in change in fasting glucose between each intervention period