Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus
NCT ID: NCT05860413
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2023-01-24
2025-05-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intermittent energy restriction (IER)
Intermittent fasting using a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week
Intermittent energy restriction (IER)
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.
Time-restricted eating (TRE)
Intermittent fasting using an 8-hour eating period.
Time Restricted Eating (TRE)
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.
Interventions
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Intermittent energy restriction (IER)
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.
Time Restricted Eating (TRE)
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.
Eligibility Criteria
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Inclusion Criteria
2. Age 21-65 years
3. BMI of 25 - 45 kg/m2
4. HbA1c of 6.7-9.5%, or those with A1c of \<6.7% on glucose-lowering medications
5. Ability to participate in a graduated physical activity program
6. Clearance from study physician.
Exclusion Criteria
2. Weight change of \>=5% in the previous 3 months.
3. Addition of new antihyperglycemic or weight-reducing medication in the previous 2 months.
4. 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.
5. Untreated depression or anxiety, or increase in associated medications in the previous 3 months.
6. Current participation in another lifestyle change intervention, such as a tobacco cessation program or physical activity program.
7. Pregnancy or lactation within the previous six months
8. Weight of \>450 lbs
9. Currently taking medications that may result in hypoglycemia during fasting and unwilling to stop prior to the study
21 Years
65 Years
ALL
No
Sponsors
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American Diabetes Association
OTHER
University of Kansas Medical Center
OTHER
Responsible Party
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Felicia Steger
Assistant Professor
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Other Identifiers
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STUDY00149127
Identifier Type: -
Identifier Source: org_study_id