Lifestyle Changes for Prediabetes

Overseen By Lena Navarro

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: Insulin, Glucose-lowering drugs

Disqualifiers: Chronic kidney disease, Hypertension, Sleep apnea, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

34 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial excludes participants who are on medications that affect insulin sensitivity, glucose concentrations, and body weight, so you may need to stop taking such medications to participate.

What data supports the effectiveness of the treatment for prediabetes?

Research shows that maintaining a consistent sleep pattern and making lifestyle changes can help control blood sugar levels in people with prediabetes. Studies have found that irregular sleep and short sleep duration are linked to a higher risk of developing diabetes, while structured lifestyle interventions can improve glucose metabolism. ^{1 2 3 4 5}

Is the lifestyle intervention for prediabetes safe for humans?

The studies suggest that lifestyle interventions, including those focusing on sleep and consistent daily routines, are generally safe for humans. These interventions have been tested in various groups, including people with prediabetes and those living with HIV, without significant safety concerns reported. ^{1 3 4 6 7}

How is the Fixed Schedule, Fixed Sleep treatment for prediabetes different from other treatments?

This treatment focuses on maintaining a consistent sleep schedule, which is unique because irregular sleep is linked to poor glucose metabolism. Unlike other treatments that may focus solely on diet and exercise, this approach emphasizes stable sleep patterns as a key component of managing prediabetes. ^{3 5 7 8 9}

What is the purpose of this trial?

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.

Research Team

Blandine Laferrere

Principal Investigator

Columbia University

Marie-Pierre St-Onge

Principal Investigator

Columbia University

Eligibility Criteria

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.

Inclusion Criteria

Your body mass index (BMI) is between 25 and 39.9.

You sleep for at least 6 hours every night, as measured by a special wrist device for 14 nights.

My A1c levels are between 5.7% and 6.4%, indicating pre-diabetes.

Exclusion Criteria

I have been diagnosed with obstructive sleep apnea.

I have a psychiatric or neurological condition.

I can travel across different time zones.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Baseline Assessment

Participants track their sleep and wear a glucose monitor to measure glucose levels

2 weeks

1 visit (in-person)

Treatment

Participants are randomized to either maintain usual habits or stabilize lifestyle behaviors

12 weeks

2 visits (in-person) at start and end

Follow-up

Participants are monitored for changes in glucose control, body composition, and liver fat

4 weeks

Treatment Details

Interventions

• Fixed Schedule
• Fixed Sleep

Trial Overview 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.

Participant Groups

Group I: Fixed Schedule Experimental Treatment 1 Intervention

Participants randomized to Fixed Schedule (FS) will be asked to stabilize their lifestyle behaviors for 12 weeks.

Group II: Variable Schedule Active Control 1 Intervention

Participants randomized to Variable Schedule (VS) will be asked to maintain their usual habits for 12 weeks.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

Findings from Research

Collaboration between sleep/circadian researchers and metabolism/diabetes experts is essential to translate basic research findings into practical strategies for improving metabolic health, particularly in the context of sleep disruption.

There is a significant opportunity to explore the effects of CPAP treatment for obstructive sleep apnea on pre-diabetes and the impact of temporal restricted feeding on obesity, which could lead to new preventative measures against diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Sleep and Circadian Disruption on Energy Balance and Diabetes: A Summary of Workshop Discussions. Arble, DM., Bass, J., Behn, CD., et al.[2022]

In a study of 522 overweight individuals with impaired glucose tolerance, long sleep duration (9-10 hours or more) was linked to a higher risk of developing type 2 diabetes, particularly in those who did not receive lifestyle intervention.

However, participants who underwent lifestyle interventions, including diet and exercise, did not show an increased diabetes risk associated with long sleep duration, suggesting that such interventions can mitigate the negative effects of excessive sleep on diabetes risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep duration, lifestyle intervention, and incidence of type 2 diabetes in impaired glucose tolerance: The Finnish Diabetes Prevention Study. Tuomilehto, H., Peltonen, M., Partinen, M., et al.[2022]

A pilot six-month intensive lifestyle intervention (ILI) program for people living with HIV and prediabetes led to significant weight loss and waist circumference reduction, indicating its effectiveness in improving metabolic control.

Increased sleep variability was linked to higher plasma glucose levels, suggesting that sleep patterns may influence the metabolic outcomes of the ILI program, highlighting the need for further research in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an intensive lifestyle intervention and the role of sleep in people living with HIV and prediabetes: a pilot and feasibility study. Nimitphong, H., Sungkanuparph, S., Areevut, C., et al.[2021]

In a study of 79 patients with prediabetes, it was found that shorter sleep duration and lower relative amplitude of rest-activity rhythms were linked to higher levels of HbA1c, indicating poorer glycemic control.

The analysis showed that lower relative amplitude was independently associated with higher HbA1c levels, suggesting that maintaining a healthy circadian rhythm may be important for preventing the progression to diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between rest-activity parameters and hemoglobin A1c in patients with prediabetes. Paewponsong, J., Gerber, BS., Anothaisintawee, T., et al.[2023]

The PROP-ABC Study involved 223 participants, with 158 starting an intensive lifestyle intervention (ILI) program aimed at reversing prediabetes, demonstrating that such interventions can be effectively implemented in a biracial cohort.

The ILI program, which included goal setting, calorie restriction, and increased physical activity, resulted in significant weight loss and improved glucose regulation, indicating its potential to restore normal glucose levels in individuals with incident prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) Study: design of lifestyle intervention. Dagogo-Jack, S., Brewer, AA., Owei, I., et al.[2022]

The pilot study involving 26 midlife women with prediabetes or metabolic syndrome showed that adding a sleep extension intervention to a lifestyle program was feasible and well-accepted.

While both groups experienced reductions in BMI and waist circumference, the most significant weight loss was observed in women who increased their sleep to 7 hours or more per night, regardless of whether they received the sleep intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Type 2 Diabetes Among Midlife Women: A Feasibility Study Comparing a Combined Sleep and Lifestyle Intervention With a Standard Lifestyle Intervention. Chesla, CA., Gay, C., Bauer, L., et al.[2021]

In a study of 94 participants (41 with normal glucose tolerance and 53 with impaired glucose tolerance), glycemic variability (GV) was found to be higher in individuals with impaired glucose tolerance, indicating a potential risk factor for diabetes.

The study revealed that higher overall carbohydrate and refined grain consumption worsened GV, while increased intake of whole grains and protein was associated with improved GV, suggesting dietary modifications could help manage glycemic fluctuations in those with impaired glucose tolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relationship Between Dietary Patterns and Glycemic Variability in People with Impaired Glucose Tolerance. Dimova, R., Chakarova, N., Del Prato, S., et al.[2023]

An adaptive intervention tailored for slow treatment responders with prediabetes showed improvements in self-regulation and dietary intake, indicating its potential effectiveness in promoting lifestyle changes.

While both the standard Group Lifestyle Balance (GLB) and the adaptive GLB Plus (GLB+) interventions led to significant reductions in energy and fat intake, the standard GLB group reported greater improvements in self-efficacy and physical activity after 4 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an augmented intervention on self-regulatory, dietary and physical activity outcomes in a diabetes prevention trial among adults with prediabetes. Miller, CK., King, D., Nagaraja, HN., et al.[2023]

In a study of 1,510 participants with prediabetes, those with both impaired fasting glucose and impaired glucose tolerance (IFG+IGT) experienced greater sustained weight loss (3.5%) after a 3-year lifestyle intervention compared to those with isolated impaired fasting glucose (iIFG), who lost 2.5%.

Participants with normal hemoglobin A1c (HbA1c) showed more significant improvements in fasting glucose and triglycerides compared to those with intermediate HbA1c, indicating that baseline HbA1c levels may influence the effectiveness of lifestyle interventions on cardiometabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the Effect of a 3-Year Lifestyle Intervention on Body Weight and Cardiometabolic Health Differ by Prediabetes Metabolic Phenotype? A Post Hoc Analysis of the PREVIEW Study. Zhu, R., Jalo, E., Silvestre, MP., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of Sleep and Circadian Disruption on Energy Balance and Diabetes: A Summary of Workshop Discussions. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Sleep duration, lifestyle intervention, and incidence of type 2 diabetes in impaired glucose tolerance: The Finnish Diabetes Prevention Study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effects of an intensive lifestyle intervention and the role of sleep in people living with HIV and prediabetes: a pilot and feasibility study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The association between rest-activity parameters and hemoglobin A1c in patients with prediabetes. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) Study: design of lifestyle intervention. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Preventing Type 2 Diabetes Among Midlife Women: A Feasibility Study Comparing a Combined Sleep and Lifestyle Intervention With a Standard Lifestyle Intervention. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The Relationship Between Dietary Patterns and Glycemic Variability in People with Impaired Glucose Tolerance. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of an augmented intervention on self-regulatory, dietary and physical activity outcomes in a diabetes prevention trial among adults with prediabetes. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Does the Effect of a 3-Year Lifestyle Intervention on Body Weight and Cardiometabolic Health Differ by Prediabetes Metabolic Phenotype? A Post Hoc Analysis of the PREVIEW Study. [2022]