Pre-diabetesNCT05224986

Lifestyle Patterns and Glycemic Control

A study testing Fixed Schedule in people with Pre-diabetes, run by Columbia University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

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. Read more about this study

Who is it for?: Ages 25 years and older
Conditions the study is for: Pre-diabetes
What is being tested?: Fixed Schedule
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 19 Jan 2022to 31 Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Columbia University Irving Medical Center
New York, New York, 10032

Other trials in United States

About this study

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.

Read the 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.

Conditions: Pre-diabetes
Being tested: Fixed Schedule
Medical subject headings: Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fixed ScheduleBehavioural
Participants will be asked to maintain a fixed schedule for 12 weeks.

Study groups in NCT05224986
Study group	Role	What they receive
Variable Schedule	No intervention	Participants randomized to Variable Schedule (VS) will be asked to maintain their usual habits for 12 weeks.
Fixed Schedule	Experimental	Participants randomized to Fixed Schedule (FS) will be asked to stabilize their lifestyle behaviors for 12 weeks. Receives: Behavioral: Fixed Schedule

What is being measured

The primary outcome is the main question the study is designed to answer.

Adipose Tissue Measurement - Total
Measuring total adiposity. Measured by MRI, includes both subcutaneous and visceral adipose tissue.
Measured: 12 weeks
Adipose Tissue Measurement - Subcutaneous
Measurement of subcutaneous adiposity using MRI.
Measured: 12 weeks
Adipose Tissue Measurement - Visceral
Measurement of visceral adiposity using MRI.
Measured: 12 weeks
Glucose Area Under Curve
Testing glycemic control.The primary outcome variable is glucose under the curve during the oral glucose tolerance test.
Measured: 12 weeks
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.
Measured: 12 weeks

Secondary outcomes (7)

Liver Fat Content
This is to assess liver fat measured by MRS and MRI in %.
Measured: 12 weeks
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.
Measured: 12 weeks
Short-term Change in Glycemia
Assessing whether short-term glycemia is changed by measuring fructosamine using two-sample t-tests.
Measured: Baseline, up to 12 weeks
Endothelial cell inflammation (sub-set, n≤10)
NF-κB nuclear fluorescence area for pilot study.
Measured: Baseline, 12 weeks
White blood cells
Leukocytes and neutrophils
Measured: Baseline, 12 weeks
Long-term Change in Glycemia
Assessing whether long-term glycemia is changed by measuring hemoglobin A1c using two-sample t-tests.
Measured: Baseline, 12 weeks
Endothelial cell oxidative stress (sub-set, n≤10)
redox sensitive fluorogenic probe fluorescence intensity for pilot study.
Measured: Baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jan 202231 Dec 2026

First posted4 Feb 2022
Study start19 Jan 2022
Primary completion30 Jun 2026
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pre-diabetesStudies of the same condition, open and under way.
More trials run by Columbia UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05224986
Sponsor's protocol ID: AAAT8914
Other IDs: R01DK128154
Status last verified: Sep 2026
First submitted: 25 Jan 2022
Last updated: 21 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pre-diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lifestyle Patterns and Glycemic Control
ClinicalTrials.gov ID: NCT05224986
Acronym / sponsor ID: AAAT8914
Conditions: Pre-diabetes
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 15 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Collaborators: Department of Health and Human Services, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 19 Jan 2022 (actual)
Primary completion: 30 Jun 2026 (actual)
Study completion: 31 Dec 2026 (estimated)
First posted: 4 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Variable Schedule	No intervention	–Participants randomized to Variable Schedule (VS) will be asked to maintain their usual habits for 12 weeks.
Fixed Schedule	Experimental	Behavioral: Fixed ScheduleParticipants randomized to Fixed Schedule (FS) will be asked to stabilize their lifestyle behaviors for 12 weeks.

Who may qualify

Ages: 25 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (11 listed)

Chronic Kidney Disease (GFR<60)
Uncontrolled hypertension (≥160/100 mmHg)
Obstructive Sleep Apnea
Psychiatric or neurological disorder
Prevalent cardiovascular disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fixed ScheduleParticipants will be asked to maintain a fixed schedule for 12 weeks.	Behavioural	Fixed Schedule

Primary outcome

Adipose Tissue Measurement - Total
Time frame: 12 weeks
Measuring total adiposity. Measured by MRI, includes both subcutaneous and visceral adipose tissue.
Adipose Tissue Measurement - Subcutaneous
Time frame: 12 weeks
Measurement of subcutaneous adiposity using MRI.
Adipose Tissue Measurement - Visceral
Time frame: 12 weeks
Measurement of visceral adiposity using MRI.
Glucose Area Under Curve
Time frame: 12 weeks
Testing glycemic control.The primary outcome variable is glucose under the curve during the oral glucose tolerance test.
Mean Amplitude of Glycemic Excursion and Standard Deviation of Mean Glucose
Time frame: 12 weeks
Testing glucose variability. The primary outcome variables are mean amplitude of glucose excursion and standard deviation of average glucose.

7 secondary outcomes

Liver Fat Content
Time frame: 12 weeks
Disposition Index
Time frame: 12 weeks
Short-term Change in Glycemia
Time frame: Baseline, up to 12 weeks
Endothelial cell inflammation (sub-set, n≤10)
Time frame: Baseline, 12 weeks
White blood cells
Time frame: Baseline, 12 weeks
Long-term Change in Glycemia
Time frame: Baseline, 12 weeks
Endothelial cell oxidative stress (sub-set, n≤10)
Time frame: Baseline, 12 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
Individual participant dataSharing planned: No

Related trials for Pre-diabetes

Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruiting
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
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Not yet recruiting
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Not yet recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marie-Pierre St-Onge principal investigator

Columbia University

Blandine Laferrere principal investigator

Columbia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fixed Schedule in people with Pre-diabetes, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adipose Tissue Measurement - Total (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05224986.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.