Back to resultsIntermittent Fasting for the Treatment of Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intermittent energy restriction (IER)
Time Restricted Eating (TRE)
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria: Diagnosed with type 2 diabetes in the past 10 years. Age 21-65 years BMI of 25 - 45 kg/m2 HbA1c of 6.7-9.5%, or those with A1c of <6.7% on glucose-lowering medications Ability to participate in a graduated physical activity program Clearance from study physician. Exclusion Criteria: Inability to attend health education meetings. Weight change of >=5% in the previous 3 months. Addition of new antihyperglycemic or weight-reducing medication in the previous 2 months. Serious medical risk such as ongoing treatment for cancer, uncontrolled hypertension, recent cardiac event, or other medical condition presenting acute risk of participation in a lifestyle change program. Untreated depression or anxiety, or increase in associated medications in the previous 3 months. Current participation in another lifestyle change intervention, such as a tobacco cessation program or physical activity program. Pregnancy or lactation within the previous six months Weight of >450 lbs Currently taking medications that may result in hypoglycemia during fasting and unwilling to stop prior to the study
Sites / Locations
- University of Kansas Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intermittent energy restriction (IER)
Time-restricted eating (TRE)
Arm Description
Intermittent fasting using a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week
Intermittent fasting using an 8-hour eating period.
Outcomes
Primary Outcome Measures
Retention
Feasibility of IER and TRE over one year assessed by retention (# completed / # enrolled) and attendance (# classes attended / # classes offered).
Adherence to diet protocols
Acceptability of IER and TRE over one year as assessed by compliance to program recommendations (# weeks adhered / # study weeks).
Secondary Outcome Measures
HbA1c
Estimate the effects for both IER and TRE on long-term glycemic control assessed via HbA1c
Oral Glucose Tolerance Test
Estimate the effects for both IER and TRE on fasting and 3 hr glucose result.
Isulin resistance
Estimate the effects for both IER and TRE on insulin resistance estimated by the oral minimal model during a mixed meal tolerance test
Insulin sensitivity
Estimate the effects for both IER and TRE on insulin sensitivity estimated by the oral minimal model during a mixed meal tolerance test
Full Information
NCT ID
NCT05860413
First Posted
February 23, 2023
Last Updated
May 5, 2023
Sponsor
University of Kansas Medical Center
Collaborators
American Diabetes Association, National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT05860413
Brief Title
Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus
Official Title
Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
Collaborators
American Diabetes Association, National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To test whether a lifestyle program featuring one of two forms of intermittent fasting (IER or TRE) can feasibly and effectively improve glycemia in patients with type 2 diabetes, and potentially induce diabetes remission.
Detailed Description
Intermittent energy restriction (IER) and time-restricted eating (TRE) are two distinct forms of intermittent fasting which have yet to be compared for the treatment of type 2 diabetes. Investigators will test whether a comprehensive, intensive lifestyle program featuring each of these intermittent fasting approaches is feasible and effective for improving glycemic control in patients diagnosed with type 2 diabetes within the past 10 years. Both interventions will be delivered over one year in three phases: (1) a 12-week weight loss program featuring weekly group meetings, (2) a 12-week weight maintenance program featuring biweekly group meetings, and (3) a 6-month low-contact follow up period featuring monthly check-ins.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intermittent energy restriction (IER)
Arm Type
Experimental
Arm Description
Intermittent fasting using a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week
Arm Title
Time-restricted eating (TRE)
Arm Type
Experimental
Arm Description
Intermittent fasting using an 8-hour eating period.
Intervention Type
Behavioral
Intervention Name(s)
Intermittent energy restriction (IER)
Intervention Description
During Phase 1 (Weight Loss), participants will follow a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week. On other days, participants do not have a specific kcal goal (non-fasting days). After Phase 1, IER participants will be instructed to follow a VLED 1-2 days per week as needed for weight maintenance.
Intervention Type
Behavioral
Intervention Name(s)
Time Restricted Eating (TRE)
Intervention Description
Participants will eat within an 8-hour period most days (at least 5 days per week). All foods and beverages containing calories will be restricted to this 8-hour period but calorie-free beverages (coffee, tea, diet soda, etc.) are allowed at any time. TRE participants will follow healthy eating guidelines for weight loss during Phase 1 but not follow a specific kcal prescription or restrict intake thereafter.
Primary Outcome Measure Information:
Title
Retention
Description
Feasibility of IER and TRE over one year assessed by retention (# completed / # enrolled) and attendance (# classes attended / # classes offered).
Time Frame
52 weeks
Title
Adherence to diet protocols
Description
Acceptability of IER and TRE over one year as assessed by compliance to program recommendations (# weeks adhered / # study weeks).
Time Frame
Weekly from baseline to 52 weeks
Secondary Outcome Measure Information:
Title
HbA1c
Description
Estimate the effects for both IER and TRE on long-term glycemic control assessed via HbA1c
Time Frame
Change from baseline to 24 weeks
Title
Oral Glucose Tolerance Test
Description
Estimate the effects for both IER and TRE on fasting and 3 hr glucose result.
Time Frame
Change from baseline to 24 weeks
Title
Isulin resistance
Description
Estimate the effects for both IER and TRE on insulin resistance estimated by the oral minimal model during a mixed meal tolerance test
Time Frame
Change from baseline to 24 weeks
Title
Insulin sensitivity
Description
Estimate the effects for both IER and TRE on insulin sensitivity estimated by the oral minimal model during a mixed meal tolerance test
Time Frame
Change from baseline to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with type 2 diabetes in the past 10 years.
Age 21-65 years
BMI of 25 - 45 kg/m2
HbA1c of 6.7-9.5%, or those with A1c of <6.7% on glucose-lowering medications
Ability to participate in a graduated physical activity program
Clearance from study physician.
Exclusion Criteria:
Inability to attend health education meetings.
Weight change of >=5% in the previous 3 months.
Addition of new antihyperglycemic or weight-reducing medication in the previous 2 months.
Serious medical risk such as ongoing treatment for cancer, uncontrolled hypertension, recent cardiac event, or other medical condition presenting acute risk of participation in a lifestyle change program.
Untreated depression or anxiety, or increase in associated medications in the previous 3 months.
Current participation in another lifestyle change intervention, such as a tobacco cessation program or physical activity program.
Pregnancy or lactation within the previous six months
Weight of >450 lbs
Currently taking medications that may result in hypoglycemia during fasting and unwilling to stop prior to the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Felicia Steger, PhD
Phone
913-735-5411
Email
fsteger@kumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Annie Eller, RD
Phone
913-735-5411
Email
aeller2@kumc.edu
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felicia Steger, PhD
Phone
913-735-5411
Email
fsteger@kumc.edu
First Name & Middle Initial & Last Name & Degree
Annie Eller, RD
Phone
913-735-5411
Email
aeller2@kumc.edu
First Name & Middle Initial & Last Name & Degree
Felicia Steger, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus
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