Columbia University Irving Medical Center
New York, 10032, United States
Location status: Recruiting
Location contact
Lara Bond
CONTACT
Marie-Pierre St-Onge
PRINCIPAL_INVESTIGATOR
Marie-Pierre St-Onge, PhD
CONTACT
NCT Number: NCT05224986
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.
Interested in participating?
Request Info25 year and older
All sexes
Interventional
Not applicable
New York, 10032, United States
Location status: Recruiting
Lara Bond
CONTACT
Marie-Pierre St-Onge
PRINCIPAL_INVESTIGATOR
Marie-Pierre St-Onge, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be asked to maintain a fixed schedule for 12 weeks.
Time frame: 12 weeks
Measuring total adiposity. Measured by MRI, includes both subcutaneous and visceral adipose tissue.
Time frame: 12 weeks
Measurement of subcutaneous adiposity using MRI.
Time frame: 12 weeks
Measurement of visceral adiposity using MRI.
Time frame: 12 weeks
Testing glycemic control.The primary outcome variable is glucose under the curve during the oral glucose tolerance test.
Time frame: 12 weeks
Testing glucose variability. The primary outcome variables are mean amplitude of glucose excursion and standard deviation of average glucose.
Time frame: 12 weeks
This is to assess liver fat measured by MRS and MRI in %.
Time frame: 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.
Time frame: Baseline, up to 12 weeks
Assessing whether short-term glycemia is changed by measuring fructosamine using two-sample t-tests.
Time frame: Baseline, 12 weeks
NF-κB nuclear fluorescence area for pilot study.
Time frame: Baseline, 12 weeks
Leukocytes and neutrophils
Time frame: Baseline, 12 weeks
Assessing whether long-term glycemia is changed by measuring hemoglobin A1c using two-sample t-tests.
Time frame: Baseline, 12 weeks
redox sensitive fluorogenic probe fluorescence intensity for pilot study.
Contact information is provided by the study sponsor or research team.
Lena Navarro
CONTACT
Marie-Pierre St-Onge
CONTACT
Columbia University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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