Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:

Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05860413
• Other study ID #: STUDY00149127
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 24, 2023
• Est. completion date: January 2026

Study information

• Verified date: May 2024
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 57
• Est. completion date: January 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Diagnosed with type 2 diabetes in the past 10 years.

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:

1. Inability to attend health education meetings.

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
University of Kansas Medical Center	American Diabetes Association, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention	Feasibility of IER and TRE over one year assessed by retention (# completed / # enrolled) and attendance (# classes attended / # classes offered).	52 weeks
Primary	Adherence to diet protocols	Acceptability of IER and TRE over one year as assessed by compliance to program recommendations (# weeks adhered / # study weeks).	Weekly from baseline to 52 weeks
Secondary	HbA1c	Estimate the effects for both IER and TRE on long-term glycemic control assessed via HbA1c	Change from baseline to 24 weeks
Secondary	Oral Glucose Tolerance Test	Estimate the effects for both IER and TRE on fasting and 3 hr glucose result.	Change from baseline to 24 weeks
Secondary	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	Change from baseline to 24 weeks
Secondary	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	Change from baseline to 24 weeks