Type 2 Diabetes
Conditions
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.
Interventions
BEHAVIORALIntermittent 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.
BEHAVIORALTime 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.
Sponsors
University of Kansas Medical Center
American Diabetes Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention | 52 weeks | Feasibility of IER and TRE over one year assessed by participant retention (% of participants completed). |
| Adherence to Diet Protocols | Weekly from baseline to 52 weeks | Acceptability of IER and TRE over one year as assessed by compliance to program recommendations (% of weeks adhered) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Change from baseline to 24 weeks | Change in glycemic control assessed via HbA1c (%) |
| Postprandial Glucose | Change from baseline to 24 weeks | Estimate the effects for both IER and TRE on fasting and mean glucose during a 3 hr mixed meal tolerance test. |
Countries
United States
Participant flow
Recruitment details
Recruitment took place from January 2023 through April 2024 at the University of Kansas Medical Center. Participants were recruited through the providers and study staff at Cray diabetes clinic, through approved study flyers distributed at the medical center, and through the Frontiers Research Participant Registry.
Pre-assignment details
57 participants were enrolled and randomized.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| HbA1c | 7.0 % glycated hemoglobin STANDARD_DEVIATION 0.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 28 |
| other Total, other adverse events | 17 / 29 | 12 / 28 |
| serious Total, serious adverse events | 0 / 29 | 0 / 28 |
Outcome results
None listed