Overweight (BMI > 25), Type 2 Diabetes
Conditions
Keywords
Randomized controlled trial, Time-restricted eating, Intermittent fasting, Type 2 diabetes
Brief summary
Time-restricted eating - 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 type 2 diabetes, it is also been shown to improve glucose control. The investigators propose a randomized controlled trial to determine whether time-restricted eating is an effective therapeutic strategy that can preserve pancreatic beta-cell function and improve glycemic control early in participants with type 2 diabetes.
Detailed description
In this study, eligible patients with type 2 diabetes will be randomized to either time-restricted eating or standard lifestyle. The hypothesis under study is whether time-restricted eating can improve pancreatic beta-cell function.
Interventions
BEHAVIORALTime-restricted eating
18 hours of fasting and 6 hour window of eating (between 2 to 8 PM) every day for 52 weeks.
BEHAVIORALStandard lifestyle
standard lifestyle recommendations as per Diabetes Canada guidelines \[where patients are encouraged to maintain regularity in timing and spacing of meals with no specific recommendation regarding hours of fasting\]
Sponsors
Mount Sinai Hospital, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Individuals with previously diagnosed BMI ≥ 25 kg/m2 and type 2 diabetes within preceding 10 years. * Age 18 - 75 years inclusive * Stable weight over past 12 weeks (less than 5% change in body weight) (self-reported) * Diabetes treatment consisting of lifestyle only or metformin, dipeptidyl peptidase-4 (DPP-4) inhibitor, and sodium-glucose co-transporter 2 (SGLT2) inhibitors either as monotherapy or in combination. * Ability to read and understand English
Exclusion criteria
* Current diabetes treatment with insulin, glucagon-like peptide-1 receptor agonists, and/or sulfonylureas. * Use of any other pharmacological treatment for weight-loss * Previous surgical treatment for weight loss such as gastric bypass or gastric band * Any history of eating disorder * Currently pregnant or lactating * Renal dysfunction as evidenced by estimated glomerular filtration rate \< 25 ml/min by CKD-EPI Creatinine Equation * New York Heart Association class II-IV heart failure * 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 * Concurrent participation in another research study relevant to diabetes and metabolic health
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in baseline-adjusted Insulin-Secretion-Sensitivity Index-2 (ISSI-2) between the study groups. | 52-weeks | Baseline-adjusted beta-cell function at 52 weeks, measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in baseline-adjusted insulin resistance between the study groups | 52-weeks | Baseline-adjusted insulin resistance at 52-weeks measured by HOMA-IR |
| Differences in time in glucose target range between each study group | 52-weeks | Time in glucose target range indicates the amount of time (in %) that glucose readings are within the defined target glucose range of 3.9-10.0 mmol/L. |
Countries
Canada
Contacts
CONTACTCaroline K Kramer, MD, PhD
Outcome results
None listed