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Lifestyle Changes for Prediabetes
N/A
Recruiting
Led By Marie-Pierre St-Onge
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pre-diabetic kg/m2 (hemoglobin A1c 5.7-6.4%)
35 years or older
Must not have
Obstructive Sleep Apnea
Psychiatric or neurological disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Summary
This trial will test whether following a set of stable lifestyle behaviors can help improve glucose control and body composition in patients with pre-diabetes.
Who is the study for?
This trial is for adults aged 35 or older with prediabetes, defined by specific blood sugar levels (hemoglobin A1c between 5.7-6.4%). Participants should have a BMI of 25-39.9 and sleep at least 6 hours nightly. Excluded are those with cardiovascular disease, certain kidney conditions, sleep apnea, recent weight loss programs, severe lipid problems, shift workers, substance abuse history, uncontrolled high blood pressure or psychiatric disorders.
What is being tested?
The study tests whether having a fixed schedule for daily activities can improve blood sugar control and body composition in people with prediabetes. It aims to see if stable lifestyle patterns reduce liver fat and help manage glucose levels better than variable lifestyles.
What are the potential side effects?
Since the intervention involves lifestyle adjustments rather than medication or medical procedures, side effects may include discomfort from changes in routine but no direct medical side effects are expected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My A1c levels are between 5.7% and 6.4%, indicating pre-diabetes.
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I am 35 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with obstructive sleep apnea.
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I have a psychiatric or neurological condition.
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I have heart disease.
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My kidney function is reduced (GFR<60).
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My blood pressure is not higher than 160/100 mmHg.
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I am currently in a weight loss program or was in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adipose Tissue Measurement - Subcutaneous
Adipose Tissue Measurement - Total
Adipose Tissue Measurement - Visceral
+2 moreSecondary study objectives
Disposition Index
Endothelial cell inflammation (sub-set, n≤10)
Endothelial cell oxidative stress (sub-set, n≤10)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Fixed ScheduleExperimental Treatment1 Intervention
Participants randomized to Fixed Schedule (FS) will be asked to stabilize their lifestyle behaviors for 12 weeks.
Group II: Variable ScheduleActive Control1 Intervention
Participants randomized to Variable Schedule (VS) will be asked to maintain their usual habits for 12 weeks.
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,857 Total Patients Enrolled
Department of Health and Human ServicesFED
230 Previous Clinical Trials
934,595 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,471 Previous Clinical Trials
2,536,316 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with obstructive sleep apnea.I have a psychiatric or neurological condition.I can travel across different time zones.I have heart disease.My kidney function is reduced (GFR<60).Your body mass index (BMI) is between 25 and 39.9.My blood pressure is not higher than 160/100 mmHg.You sleep for at least 6 hours every night, as measured by a special wrist device for 14 nights.You have high levels of fats in your blood (triglycerides ≥200 mg/dL).My A1c levels are between 5.7% and 6.4%, indicating pre-diabetes.I am 35 years old or older.Your bedtime changes a lot, and the difference between your bedtimes is at least 45 minutes.I am taking medication that affects my insulin sensitivity, blood sugar, or weight.I am currently in a weight loss program or was in the last 3 months.You do not work night shifts or rotating shifts.You have a history of alcohol or drug abuse.
Research Study Groups:
This trial has the following groups:- Group 1: Variable Schedule
- Group 2: Fixed Schedule
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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