Clinical trial NCT05860413: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2023-05-16
Enrollment: 57
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Retention
timeFrame: 52 weeks
measure: Adherence to diet protocols
timeFrame: Weekly from baseline to 52 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: Change from baseline to 24 weeks
measure: Oral Glucose Tolerance Test
timeFrame: Change from baseline to 24 weeks
measure: Isulin resistance
timeFrame: Change from baseline to 24 weeks
measure: Insulin sensitivity
timeFrame: Change from baseline to 24 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References: