Lifestyle Patterns and Glycemic Control

Pre-diabetes Clinical Trial

Official title:

Lifestyle Patterns and Glycemic Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05224986
• Other study ID #: AAAT8914
• Secondary ID: R01DK128154
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: Columbia University
• Contact: Marie-Pierre St-Onge
• Phone: 212-851-5578
• Email: ms2554[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pre-diabetes
• Prediabetic State

Intervention

Behavioral:
• Fixed Schedule
Participants will be asked to maintain a fixed schedule for 12 weeks.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Department of Health and Human Services, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adipose Tissue Measurement - Total	Measuring total adiposity. Measured by MRI, includes both subcutaneous and visceral adipose tissue.	12 weeks
Primary	Adipose Tissue Measurement - Subcutaneous	Measurement of subcutaneous adiposity using MRI.	12 weeks
Primary	Adipose Tissue Measurement - Visceral	Measurement of visceral adiposity using MRI.	12 weeks
Primary	Glucose Area Under Curve	Testing glycemic control.The primary outcome variable is glucose under the curve during the oral glucose tolerance test.	12 weeks
Primary	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.	12 weeks
Secondary	Liver Fat Content	This is to assess liver fat measured by MRS and MRI in %.	12 weeks
Secondary	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.	12 weeks
Secondary	Short-term Change in Glycemia	Assessing whether short-term glycemia is changed by measuring fructosamine using two-sample t-tests.	Baseline, up to 12 weeks
Secondary	Endothelial cell inflammation (sub-set, n=10)	NF-?B nuclear fluorescence area for pilot study.	Baseline, 12 weeks
Secondary	White blood cells	Leukocytes and neutrophils	Baseline, 12 weeks
Secondary	Long-term Change in Glycemia	Assessing whether long-term glycemia is changed by measuring hemoglobin A1c using two-sample t-tests.	Baseline, 12 weeks
Secondary	Endothelial cell oxidative stress (sub-set, n=10)	redox sensitive fluorogenic probe fluorescence intensity for pilot study.	Baseline, 12 weeks