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Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Time restricted feeding
Standard lifestyle
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Leadership Sinai Centre foe Diabetes - Mount Sinai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intermittent fasting (time restricted feeding)

Standard lifestyle

Arm 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).

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Fasting glucose
Difference in change in fasting glucose between each intervention period

Full Information

First Posted
January 20, 2023
Last Updated
January 30, 2023
Sponsor
Mount Sinai Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT05717127
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mount Sinai Hospital, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intermittent fasting (time restricted feeding)
Arm Type
Experimental
Arm 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).
Arm Title
Standard lifestyle
Arm Type
Active Comparator
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
Time restricted feeding
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Standard lifestyle
Intervention Description
Standard lifestyle recommendations
Primary Outcome Measure Information:
Title
Pancreatic beta-cell function
Description
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 Outcome Measure Information:
Title
Fasting glucose
Description
Difference in change in fasting glucose between each intervention period
Time Frame
at week 16
Other Pre-specified Outcome Measures:
Title
BMI
Description
Difference in change in BMI between each intervention period
Time Frame
at week 16
Title
Waist circumference
Description
Difference in change in waist circumference between each intervention period
Time Frame
at week 16
Title
Central abdominal fat mass on Dual X-ray Absorptiometry (DEXA)
Description
Difference in change in central abdominal mass between each intervention period
Time Frame
at week 16
Title
Insulin sensitivity
Description
Difference in insulin sensitivity measured by the Matsuda Index between each intervention period
Time Frame
at week 16
Title
Satiety
Description
Difference in hunger assessed by Visual Analogue Scales (0 to 10mm with increased values associated with increased hunger) between each intervention period
Time Frame
at week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline K Kramer, MD
Phone
4165864800
Ext
7628
Email
caroline.kramer@sinaihealth.ca
Facility Information:
Facility Name
Leadership Sinai Centre foe Diabetes - Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3L9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline K Kramer, Md PhD
Phone
4165864800
Ext
7628

12. IPD Sharing Statement

Plan to Share IPD
No

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Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes

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