Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT05860413|
Recruitment Status : Recruiting
First Posted : May 16, 2023
Last Update Posted : May 16, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Behavioral: Intermittent energy restriction (IER) Behavioral: Time Restricted Eating (TRE)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus|
|Actual Study Start Date :||January 24, 2023|
|Estimated Primary Completion Date :||July 2025|
|Estimated Study Completion Date :||January 2026|
Experimental: Intermittent energy restriction (IER)
Intermittent fasting using a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week
Behavioral: 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.
Experimental: Time-restricted eating (TRE)
Intermittent fasting using an 8-hour eating period.
Behavioral: 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.
- Retention [ Time Frame: 52 weeks ]Feasibility of IER and TRE over one year assessed by retention (# completed / # enrolled) and attendance (# classes attended / # classes offered).
- Adherence to diet protocols [ Time Frame: Weekly from baseline to 52 weeks ]Acceptability of IER and TRE over one year as assessed by compliance to program recommendations (# weeks adhered / # study weeks).
- HbA1c [ Time Frame: Change from baseline to 24 weeks ]Estimate the effects for both IER and TRE on long-term glycemic control assessed via HbA1c
- Oral Glucose Tolerance Test [ Time Frame: Change from baseline to 24 weeks ]Estimate the effects for both IER and TRE on fasting and 3 hr glucose result.
- Isulin resistance [ Time Frame: Change from baseline to 24 weeks ]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 [ Time Frame: Change from baseline to 24 weeks ]Estimate the effects for both IER and TRE on insulin sensitivity estimated by the oral minimal model during a mixed meal tolerance test
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|Ages Eligible for Study:||21 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05860413
|Contact: Felicia Steger, PhDfirstname.lastname@example.org|
|Contact: Annie Eller, RDemail@example.com|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Contact: Felicia Steger, PhD 913-735-5411 firstname.lastname@example.org|
|Contact: Annie Eller, RD 913-735-5411 email@example.com|
|Principal Investigator: Felicia Steger, PhD|
|Responsible Party:||Felicia Steger, Assistant Professor, University of Kansas Medical Center|
|Other Study ID Numbers:||
|First Posted:||May 16, 2023 Key Record Dates|
|Last Update Posted:||May 16, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases