Effect of Increased Physical Activity and Stopping Evening Snacking in Metabolic Health in Youth With Prediabetes

NCT06782906 | Recruiting

• 2 other identifiers: H-5632158-3092-5-008
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Non-healthy eating habits and a lack of exercise contribute to prediabetes and type 2 diabetes (T2D). Evening snacking is linked to abnormal weight gain in adults and healthy adolescents. Most adolescents do not get enough exercise. This study aims to look at the benefits of more exercise and stopping evening snacking in youth with prediabetes. The study lasts 8 weeks, and participants will be randomly assigned to either an intervention group or a standard of care group.

Conditions

Prediabetes

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity index for glucose disposal (ISI [Gly]) during oral glucose tolerance test

  Insulin sensitivity index for glycemia (ISI \[Gly\]) will be calculated with a formula using insulin and glucose area under the curves during oral glucose tolerance tests (OGTT) as described previously (Belfiore et al., Metabolism, 2001): ISI (Gly) = 2 / \[INSp x GLYp) + 1\] INSp: insulinemic area during OGTT with 3 (0, 1h and 2h) or 5 sampling (0, 30, 60, 90 and 120 min) GLYp: glycemic area during OGTT (0, 1h and 2h) or 5 sampling (0, 30, 60, 90 and 120 min) INSp and GLYp are expressed by taking the mean normal value as 1, i.e., by dividing the value observed in the person under study by the mean normal value so that, if INSp (or GLYp) is 1.5-fold the mean normal values, it will be considered as equal to 1.5, and so on. We will use appropriate "mean normal values," which will be derived from data obtained in our laboratory.

  At week 9-10 following completion of 8 weeks of intervention period

Secondary Outcomes (10)

• index for fat disposal (ISI [FFA]) during oral glucose tolerance test

  At week 9-10 following completion of 8 weeks of intervention period

• HbA1c

  At week 9-10 following completion of 8 weeks of intervention period

• Percentage of adiposity (percent body fat)

  At week 9-10 following completion of 8 weeks of intervention period

• Amino acid concentrations

  At week 9-10 following completion of 8 weeks of intervention period

• Adiponectin

  At week 9-10 following completion of 8 weeks of intervention period

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Participants in the intervention arm will be asked to perform ≥10,000 daily steps (≥5 days/week) and omit evening snacking after 8:00 p.m.

Behavioral: ≥10,000 daily steps (≥5 days/week) and stopping evening snacking

Standard of Care Arm

NO INTERVENTION

Participants in the standard of care arm will be asked to follow recommendations of their physician.

Interventions

≥10,000 daily steps (≥5 days/week) and stopping evening snacking BEHAVIORAL

Participants in the intervention arm will be asked to perform ≥10,000 daily steps (≥5 days/week) and omit evening snacking after 8:00 p.m.

Intervention Arm

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age
• Having a diagnosis of prediabetes
• Engaging in frequent evening snacking
• Inadequate physical activity

You may not qualify if:

• Diagnosis of diabetes
• Significant history of chronic disease
• Evidence of significant liver or kidney disease;
• Any hormone replacement therapy; and
• Pregnancy.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital / Children's Nutrition Research Center / Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mustafa Tosur, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa Tosur, MD

CONTACT

832-822-3780; mustafa.tosur@bcm.edu

Lori Malone

CONTACT

713-798-1070; lmalone@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 20, 2025
• Study Start: May 13, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)