Clinical trial NCT05717127: Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes
Official title: Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pancreatic beta-cell function
timeFrame: at week 16
Secondary outcomes:
measure: Fasting glucose
timeFrame: at week 16
Other outcomes:
measure: BMI
timeFrame: at week 16
measure: Waist circumference
timeFrame: at week 16
measure: Central abdominal fat mass on Dual X-ray Absorptiometry (DEXA)
timeFrame: at week 16
measure: Insulin sensitivity
timeFrame: at week 16
measure: Satiety
timeFrame: at week 16
Locations:
city: Toronto
country: Canada
facility: Leadership Sinai Centre foe Diabetes - Mount Sinai Hospital
state: Ontario
Study officials:
References: