Clinical trial NCT05224986: Lifestyle Patterns and Glycemic Control
Official title: Lifestyle Patterns and Glycemic Control
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pre-diabetes
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-02-04
Enrollment: 34
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adipose Tissue Measurement - Total
timeFrame: 12 weeks
measure: Adipose Tissue Measurement - Subcutaneous
timeFrame: 12 weeks
measure: Adipose Tissue Measurement - Visceral
timeFrame: 12 weeks
measure: Glucose Area Under Curve
timeFrame: 12 weeks
measure: Mean Amplitude of Glycemic Excursion and Standard Deviation of Mean Glucose
timeFrame: 12 weeks
Secondary outcomes:
measure: Liver Fat Content
timeFrame: 12 weeks
measure: Disposition Index
timeFrame: 12 weeks
measure: Short-term Change in Glycemia
timeFrame: Baseline, up to 12 weeks
measure: Endothelial cell inflammation (sub-set, n≤10)
timeFrame: Baseline, 12 weeks
measure: White blood cells
timeFrame: Baseline, 12 weeks
measure: Long-term Change in Glycemia
timeFrame: Baseline, 12 weeks
measure: Endothelial cell oxidative stress (sub-set, n≤10)
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Marie-Pierre St-Onge
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Blandine Laferrere
role: PRINCIPAL_INVESTIGATOR
References: