Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes

Obesity Clinical Trial

Official title:

Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05717127
• Other study ID #: 19-0299-A
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: January 2023
• Source: Mount Sinai Hospital, Canada
• Contact: Caroline K Kramer, MD
• Phone: 4165864800
• Email: caroline.kramer[@]sinaihealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Behavioral:
• Time restricted feeding
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).
• Standard lifestyle
Standard lifestyle recommendations

Locations

Country	Name	City	State
Canada	Leadership Sinai Centre foe Diabetes - Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BMI	Difference in change in BMI between each intervention period	at week 16
Other	Waist circumference	Difference in change in waist circumference between each intervention period	at week 16
Other	Central abdominal fat mass on Dual X-ray Absorptiometry (DEXA)	Difference in change in central abdominal mass between each intervention period	at week 16
Other	Insulin sensitivity	Difference in insulin sensitivity measured by the Matsuda Index between each intervention period	at week 16
Other	Satiety	Difference in hunger assessed by Visual Analogue Scales (0 to 10mm with increased values associated with increased hunger) between each intervention period	at week 16
Primary	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)	at week 16
Secondary	Fasting glucose	Difference in change in fasting glucose between each intervention period	at week 16