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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
15
Participants will be asked to maintain a fixed schedule for 12 weeks.
Columbia University Irving Medical Center
New York, New York, United States
Adipose Tissue Measurement - Total
Measuring total adiposity. Measured by MRI, includes both subcutaneous and visceral adipose tissue.
Time frame: 12 weeks
Adipose Tissue Measurement - Subcutaneous
Measurement of subcutaneous adiposity using MRI.
Time frame: 12 weeks
Adipose Tissue Measurement - Visceral
Measurement of visceral adiposity using MRI.
Time frame: 12 weeks
Glucose Area Under Curve
Testing glycemic control.The primary outcome variable is glucose under the curve during the oral glucose tolerance test.
Time frame: 12 weeks
Mean Amplitude of Glycemic Excursion and Standard Deviation of Mean Glucose
Testing glucose variability. The primary outcome variables are mean amplitude of glucose excursion and standard deviation of average glucose.
Time frame: 12 weeks
Liver Fat Content
This is to assess liver fat measured by MRS and MRI in %.
Time frame: 12 weeks
Disposition Index
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.
Time frame: 12 weeks
Short-term Change in Glycemia
Assessing whether short-term glycemia is changed by measuring fructosamine using two-sample t-tests.
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Time frame: Baseline, up to 12 weeks
Endothelial cell inflammation (sub-set, n≤10)
NF-κB nuclear fluorescence area for pilot study.
Time frame: Baseline, 12 weeks
White blood cells
Leukocytes and neutrophils
Time frame: Baseline, 12 weeks
Long-term Change in Glycemia
Assessing whether long-term glycemia is changed by measuring hemoglobin A1c using two-sample t-tests.
Time frame: Baseline, 12 weeks
Endothelial cell oxidative stress (sub-set, n≤10)
redox sensitive fluorogenic probe fluorescence intensity for pilot study.
Time frame: Baseline, 12 weeks