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Behavioral Intervention
Intermittent Fasting for Type 2 Diabetes
N/A
Recruiting
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with type 2 diabetes in the past 10 years
BMI of 25 - 45 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
Study Summary
This trial tests if lifestyle changes with two forms of fasting can help diabetes patients and may even lead to remission.
Who is the study for?
This trial is for adults aged 21-65 with type 2 diabetes diagnosed within the last decade, having a BMI of 25-45 and an HbA1c level between 6.7-9.5%. Participants should be able to exercise and get clearance from the study physician. Those pregnant, lactating, on certain medications, or with recent serious medical issues can't join.Check my eligibility
What is being tested?
The trial is examining if intermittent fasting—either Intermittent Energy Restriction (IER) or Time Restricted Eating (TRE)—can help control blood sugar levels in type 2 diabetes patients and possibly lead to remission of the disease.See study design
What are the potential side effects?
Potential side effects may include feelings of hunger, weakness during fasting periods, headaches, dizziness due to changes in blood sugar levels, and possible digestive discomfort when eating resumes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with type 2 diabetes within the last 10 years.
Select...
My BMI is between 25 and 45.
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I am between 21 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to diet protocols
Retention
Secondary outcome measures
HbA1c
Insulin sensitivity
Isulin resistance
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Time-restricted eating (TRE)Experimental Treatment1 Intervention
Intermittent fasting using an 8-hour eating period.
Group II: Intermittent energy restriction (IER)Experimental Treatment1 Intervention
Intermittent fasting using a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week
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Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
463 Previous Clinical Trials
169,214 Total Patients Enrolled
American Diabetes AssociationOTHER
139 Previous Clinical Trials
99,550 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,794 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious health condition that could make lifestyle changes risky.You can take part in a program that gradually increases physical activity.I was diagnosed with type 2 diabetes within the last 10 years.My HbA1c level is between 6.7-9.5%, or it's below 6.7% but I'm on medication to lower it.I cannot attend health education meetings.I am on medication that can lower my blood sugar and cannot stop it for the study.You were pregnant or breastfeeding in the last six months.My BMI is between 25 and 45.I have not started treatment for depression or anxiety, nor increased my medication in the last 3 months.You are currently involved in another program to help you change your habits, like quitting smoking or increasing physical activity.I am between 21 and 65 years old.I haven't started any new diabetes or weight loss meds in the last 2 months.You weigh more than 450 pounds.You have gained or lost 5% or more of your body weight in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Time-restricted eating (TRE)
- Group 2: Intermittent energy restriction (IER)
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.
What is the size of the cohort participating in this research?
"Affirmative. According to clinicaltrials.gov, the medical trial first posted on January 24th 2023 is actively searching for participants and has been updated as recently as May 5th 2023. 56 patients need to be enrolled from a single centre."
Answered by AI
What are the foremost aims of this trial?
"During the course of this year-long study, investigators will track adherence to dietary protocols as its primary outcomes. Secondary assessments include insulin resistance and sensitivity estimated by oral minimal models during mixed meal tolerance tests, alongside long term glycemic control evaluated through Hemoglobin A1c (HbA1C)."
Answered by AI
Could I potentially qualify to join this research initiative?
"This clinical trial seeks to enroll 56 individuals between the ages of 21 and 65 who suffer from type 2 diabetes."
Answered by AI
Does the eligibility for this experiment extend to those in their golden years?
"This study stipulates that the lowest permissible age for enrolment is 21, while the upper limit is 65 years old."
Answered by AI
Is enrollment for this experiment available to participants?
"According to the publicly available information on clinicaltrials.gov, this medical study is in search of participants. The trial was originally launched on January 24th 2023 and most recently modified on May 5th 2023."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
What site did they apply to?
University of Kansas Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
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