Pre-diabetes
Conditions
Brief summary
The goal of the proposed study is to evaluate the feasibility and initial efficacy of stabilizing lifestyle behaviors to improve glucose control and body composition in patients with pre-diabetes. The investigator proposes that following stable lifestyle behaviors will improve patients' glucose control, body composition, and liver fat. The results from this study has the potential to impact clinical practice and patient care.
Detailed description
Variability in lifestyle behaviors has been associated with adverse health, specifically poor glucose control. The project proposes to test whether reducing this variability improves glycemia in patients with pre-diabetes. If successful, this simple positive lifestyle message to keep stable behaviors has the potential to improve the health of millions of adults worldwide. This project will enroll participants with pre-diabetes who have erratic lifestyle behaviors and randomize them to either maintain their usual habits (control group) or stabilize their behaviors (stability group). Both groups will be followed for 12 weeks. Before the start of the 12-week period, all participants will track their sleep for 2 weeks and will wear a glucose monitor to measure their glucose levels. At the start and end of the 12-week period, they will come to the research lab to undergo a glucose tolerance test. This test will measure how their body reacts to a glucose load. They will also undergo magnetic resonance imaging and spectroscopy scanning. This scan will provide information on body composition and liver fat content.
Interventions
BEHAVIORALFixed Schedule
Participants will be asked to maintain a fixed schedule for 12 weeks.
Sponsors
Columbia University
Department of Health and Human Services
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants will not be blinded to the intervention or purpose of the study but will be told that rest-activity patterns will be examined in the context of well-being and that we will test the influence of these lifestyle patterns on glucose control and body composition. Although the investigators and research assistant directly involved in the conduct of the study cannot be blinded to participant assignment to the intervention or control group, the technicians involved in sample processing and the biostatistician (Dr. Cheng) will be blinded to this information to reduce the risk of bias.
Intervention model description
A randomized, parallel-arm clinical intervention study to assess the role of variability in lifestyle behaviors on glucose control and body composition in adults with pre-diabetes. The goal is to test whether following a fixed schedule improves glucose control and insulin sensitivity and reduces adiposity compared to those who maintain a variable schedule.
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pre-diabetic kg/m2 (hemoglobin A1c 5.7-6.9%) * 25 years or older * BMI between 25-39.9 kg/m2 * Sleep duration ≥6 hours a night assessed with wrist actigraphy (for 14 nights) * Variable bedtime, SD≥45 minutes.
Exclusion criteria
* Chronic Kidney Disease (GFR\<60) * Uncontrolled hypertension (≥160/100 mmHg) * Obstructive Sleep Apnea * Psychiatric or neurological disorder * Prevalent cardiovascular disease * Dyslipidemia (triglycerides≥200 mg/dL) * Medications that affect insulin sensitivity, glucose concentrations, and body weight * Non-day or rotating shift workers * Travel across time zones * Active participation in weight loss program or within past 3 months * Current or past alcohol/drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adipose Tissue Measurement - Total | 12 weeks | Measuring total adiposity. Measured by MRI, includes both subcutaneous and visceral adipose tissue. |
| Adipose Tissue Measurement - Subcutaneous | 12 weeks | Measurement of subcutaneous adiposity using MRI. |
| Adipose Tissue Measurement - Visceral | 12 weeks | Measurement of visceral adiposity using MRI. |
| Glucose Area Under Curve | 12 weeks | Testing glycemic control.The primary outcome variable is glucose under the curve during the oral glucose tolerance test. |
| Mean Amplitude of Glycemic Excursion and Standard Deviation of Mean Glucose | 12 weeks | Testing glucose variability. The primary outcome variables are mean amplitude of glucose excursion and standard deviation of average glucose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver Fat Content | 12 weeks | This is to assess liver fat measured by MRS and MRI in %. |
| Disposition Index | 12 weeks | This is to assess disposition index, measured using HOMA-IR. The disposition index is the product of the insulogenic index and homeostatic model of assessment for insulin resistance. |
| Short-term Change in Glycemia | Baseline, up to 12 weeks | Assessing whether short-term glycemia is changed by measuring fructosamine using two-sample t-tests. |
| Endothelial cell inflammation (sub-set, n≤10) | Baseline, 12 weeks | NF-κB nuclear fluorescence area for pilot study. |
| White blood cells | Baseline, 12 weeks | Leukocytes and neutrophils |
| Long-term Change in Glycemia | Baseline, 12 weeks | Assessing whether long-term glycemia is changed by measuring hemoglobin A1c using two-sample t-tests. |
| Endothelial cell oxidative stress (sub-set, n≤10) | Baseline, 12 weeks | redox sensitive fluorogenic probe fluorescence intensity for pilot study. |
Countries
United States
Contacts
CONTACTMarie-Pierre St-Onge
CONTACTLena Navarro
PRINCIPAL_INVESTIGATORMarie-Pierre St-Onge
Columbia University
PRINCIPAL_INVESTIGATORBlandine Laferrere
Columbia University
Outcome results
None listed