PreDiabetes
Conditions
Brief summary
One in three American adults have prediabetes, and up to 70% of adults with prediabetes eventually develop type 2 diabetes. With the high cost of treating diabetes, cost-effective approaches are needed to reduce the incidence of diabetes. One new strategy may be to change when people eat. Studies in rodents suggest that a form of intermittent fasting that limits eating to a short time period each day and involves fasting for the rest of the day (time-restricted eating; TRE) improves blood sugar control and cardiovascular health. Preliminary studies suggest that TRE also improves blood sugar, weight loss, and cardiovascular health in humans. This study will be the first full-scale, controlled feeding trial to determine whether TRE can improve 24-hour blood sugar control, 24-hour blood pressure, and cardiovascular disease risk factors even when food intake is matched to the control group. This clinical trial will also determine whether the benefits of TRE depend on the time of day that people eat. Participants will be assigned to one of three groups: (1) 'Early TRE' (eat between \ 8 am-3 pm), (2) 'Mid-day TRE' (eat between \ 1 pm - 8 pm), or (3) Control Schedule (\ 8 am - 8 pm) for 8 weeks. All food will be provided and matched between groups.
Interventions
BEHAVIORALEarly TRE
Eat between 8 am - 3 pm (or 7 am - 2 pm, if an early riser)
BEHAVIORALMid-day TRE
Eat between 1 pm - 8 pm (or 12 pm - 7 pm, if an early riser)
BEHAVIORALControl Schedule
Eat between 8 am - 8 pm (or 7 am - 7 pm, if an early riser)
Sponsors
University of Alabama at Birmingham
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Randomization will be stratified by fasting insulin. Within the lowest insulin strata, randomization will be further stratified by biological sex.
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Aged 30-70 years old * Prediabetic as determined by HbA1c between 5.7-6.4% or fasting glucose between 100-125 mg/dl with HbA1c \>= 5.1% * Fasting insulin less than 100.0 mU/l and, if HbA1c \<5.7%, must also have fasting insulin \>= 8.0 mU/l * BMI between 30-60 kg/m\^2 * Wake up at a regular time between 5-8 am
Exclusion criteria
* Been diagnosed with diabetes or on diabetes medication or any medication known to affect glucose or 24-hour rhythms in blood pressure * On weight loss medication * Change in the dosage of a chronic medication within the past 2 months * Have a clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels) * Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones * Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise the participant's safety or data validity * Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years * Pregnant or breastfeeding * Diagnosed psychiatric conditions * Sleep disorder, circadian disorder, or regularly sleep less than 6 hours per night * Major change in health or medical history in the past 3 months * Currently perform overnight shift work * Regularly eat within a \<10.5-hour period each day * Lost or gained more than 4% of weight in the past 2 months * Traveled more than 2 time zones away in the 2 months prior to enrolling in this study * Will travel outside the Central time zone in the 2 weeks prior to testing * Will travel more than 1 time zone away during this study * Behavioral factors or other circumstances that may make it difficult for you to follow the study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean 24-hour glucose levels | 8 weeks | Mean 24-hour glucose levels (mg/dl) |
| Mean 24-hour insulin levels | 8 weeks | Mean 24-hour insulin levels (mU/l) |
| Mean 24-hour C-peptide levels | 8 weeks | Mean 24-hour C-peptide levels (pmol/l). This is also a proxy for total 24-hour insulin secretion. |
| Insulin sensitivity | 8 weeks | Mean value of insulin sensitivity (dl/kg/min/μU/ml) across the three identical meal tolerance tests, as measured by the Oral Minimal Model |
| Beta-cell responsivity index (a measure of beta-cell function) | 8 weeks | Mean value of beta-cell responsivity across the three identical meal tolerance tests, as measured by the Oral Minimal Model |
| Glucose AUCs | 8 weeks | Glucose area-under-the-curve (mg/dl x hr) during each of three identical meal tolerance tests within a 24-hour period |
| Insulin AUC | 8 weeks | Insulin area-under-the-curve (mU/l x hr) during each of three identical meal tolerance tests within a 24-hour period |
| C-peptide AUC | 8 weeks | C-peptide area-under-the-curve (pmol/l x hr) during each of three identical meal tolerance tests within a 24-hour period |
| Peak glucose and mean amplitude of glycemic excursions (MAGE) glucose values | 8 weeks | mg/dl |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean 24-hour systolic and diastolic blood pressure | 8 weeks | mmHg |
| Daily maximum value, minimum value, and amplitude of systolic and diastolic blood pressure | 8 weeks | mmHg |
| Percentage of individuals with non-dipping blood pressure phenotypes | 8 weeks | — |
| Heart Rate | 8 weeks | beats per minute |
| Lipids | 8 weeks | Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl) |
| High Sensitivity C-Reactive Protein (hs-CRP) | 8 weeks | mg/l |
| Cortisol | 8 weeks | μg/dl |
| 8-isoprostane | 8 weeks | pg/ml |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCourtney M. Peterson, Ph.D.
University of Alabama at Birmingham
Outcome results
None listed