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Intermittent Fasting for Type 2 Diabetes
N/A
Recruiting
Research Sponsored by Mount Sinai Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diabetes treatment consisting of lifestyle only, metformin or dipeptidyl peptidase-4 (DPP-4) inhibitor either as monotherapy or in combination
Age 20-70 years inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 16
Awards & highlights
Study Summary
This trial will examine if IF can improve the ability of the pancreas to produce insulin in people with early T2DM, as it has been shown to improve cardio-metabolic function and reduce sugar levels.
Who is the study for?
This trial is for adults aged 20-70 with early type 2 diabetes, diagnosed within the last 10 years, who are overweight and currently managing their condition through diet, metformin or DPP-4 inhibitors. It's not open to those on complex diabetes treatments like insulin, have liver disease, a history of eating disorders or other health issues that could affect participation.Check my eligibility
What is being tested?
The study is testing if intermittent fasting (IF), which means going without food for certain periods, can improve the function of beta-cells in the pancreas among people with early type 2 diabetes. Participants will either follow IF or maintain standard lifestyle habits to see if there's an impact on their body's ability to manage blood sugar levels.See study design
What are the potential side effects?
Intermittent fasting may lead to hunger pangs, headaches, dizziness during fasting periods especially at the beginning. Long-term effects are unknown but it might also influence energy levels and mood.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I manage my diabetes with diet, exercise, metformin, or DPP-4 inhibitors.
Select...
I am between 20 and 70 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pancreatic beta-cell function
Secondary outcome measures
Fasting glucose
Other outcome measures
BMI
Central abdominal fat mass on Dual X-ray Absorptiometry (DEXA)
Insulin sensitivity
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intermittent fasting (time restricted feeding)Experimental Treatment1 Intervention
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).
Group II: Standard lifestyleActive Control1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time restricted feeding
2019
Completed Phase 2
~880
Find a Location
Who is running the clinical trial?
Mount Sinai Hospital, CanadaLead Sponsor
196 Previous Clinical Trials
67,558 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with type 2 diabetes in the last 10 years.You are overweight, with a body mass index of 25 or higher.I have had cancer treatment other than for basal cell skin cancer in the last 5 years.I have significant liver issues, like jaundice or hepatitis, or my liver tests are high.I am not participating in any other clinical trials that involve lifestyle changes or drug treatments.I manage my diabetes with diet, exercise, metformin, or DPP-4 inhibitors.You have ever had an eating disorder.My kidney function is low, with a filtration rate under 45 mL/min.I am currently being treated for diabetes with insulin or specific diabetes medications.Your HbA1c level is between 5.5% and 9.0%.I am between 20 and 70 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Intermittent fasting (time restricted feeding)
- Group 2: Standard lifestyle
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research program accept volunteers over the age of 40?
"Eligible participants must be between 20 and 70 years old."
Answered by AI
What is the current figure of enrollees in this clinical trial?
"Affirmative. Per the information posted on clinicaltrials.gov, this investigation is actively searching for participants; it was inaugurated on September 1st 2021 and last updated January 30th 2023. A total of 50 individuals need to be recruited from one centre."
Answered by AI
Would I be eligible to partake in this experiment?
"To be accepted into this clinical trial, enrollees must have type 2 diabetes and fall between the ages of 20 and 70. The study is looking for a total of 50 people to participate."
Answered by AI
Are there any vacancies in this medical experiment?
"Affirmative. This medical trial, initially posted on September 1st 2021 and recently amended on January 30th 2023 is actively searching for qualified candidates; the study seeks 50 participants from one site."
Answered by AI
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