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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
I am 35 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adipose Tissue Measurement - Subcutaneous
Adipose Tissue Measurement - Total
Adipose Tissue Measurement - Visceral
+2 moreSecondary outcome measures
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.
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,433 Previous Clinical Trials
2,460,981 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,315,461 Total Patients Enrolled
Department of Health and Human ServicesFED
226 Previous Clinical Trials
928,915 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the projected results of this medical experiment?
"The purpose of this 12 week trial is to measure visceral adipose tissue. Secondary objectives include assessing liver fat content via MRS and MRI imaging, leukocyte/neutrophil count, and a disposition index calculated using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)."
Answered by AI
What is the total enrolment of participants in this experiment?
"Affirmative. Clinicaltrials.gov claims that this clinical trial is actively seeking participants, with the first post date being January 19th 2022 and a most recent update on September 6th 2022. 34 patients need to be enlisted at 1 medical site for successful completion of the study."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Columbia University Irving Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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