Clinical trial NCT06782906: Effect of Increased Physical Activity and Stopping Evening Snacking in Metabolic Health in Youth With Prediabetes
Official title: Effect of Increased Physical Activity and Stopping Evening Snacking in Metabolic Health in Youth With Prediabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prediabetes
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Poor nutrition in addition to a lack of physical activity play significant roles in childhood T2D development, primarily by negatively affecting adiposity and insulin action in concert with other T2D risk factors. Many aspects of nutrition, including frequency of eating, were examined in relation to obesity/increased adiposity and T2D risk. Previous studies suggest increased snacking may cause overeating, and potentially lead to weight gain.

Findings from adolescents in the 2005-2016 National Health and Nutrition Examination Survey (NHANES), showed those with overweight/obesity consume more snacks per day (1.85 and 1.97 snacks per day, respectively) and more calories per snack (305 and 340 kcal/snack, respectively) than their normal-weight peers (1.69 and 262 kcal/snack).Snack consumption in adolescents is also correlated with higher daily energy intake, lower fruit/vegetable intake, along with more frequent fast-food and sugar-sweetened beverage consumptions. The timing of snacking occasions has also emerged as a potential confounder. Among adults, greater evening snacking was associated with higher BMI and higher obesogenic dietary index (e.g., intake of fast food, etc.) while greater morning snacking was associated with increased fruit and vegetable consumption. Having a bedtime snack was associated with increased odds of overweight/obesity (1.47, 95% CI: 1.34-1.62) in Japanese women. Evening snacking was also shown to be independently correlated with overweight/obesity in Italian adolescents (RR 3.12, 95% CI: 1.17-8.34). In the Healthy Growth Study, children who had high-energy intake at dinner and evening snacking were more likely to skip breakfast - a metabolically unhealthy habit.

Also, despite the known metabolic benefits of physical activity, only 1 in 4 adolescents achieve recommended daily physical activity goals (60-min, moderate-to-vigorous physical activity (MVPA)/day).Both snacking and exercise may also affect metabolic health by independently modulating gene expression levels of critical metabolic pathways and subsequently intracellular signaling. Metabolic dysregulation resulting in altered plasma concentrations of several amino acids (e.g., higher branch-chain amino acid and lower glycine concentrations, etc.) was associated with insulin resistance.

Therefore, targeted interventions towards evening snacking and increased physical activity may prove beneficial in adolescents with prediabetes by preventing progression to T2D.

Eligibility criteria: Inclusion Criteria:

1. 12-18 years of age
2. Having a diagnosis of prediabetes
3. Engaging in frequent evening snacking
4. Inadequate physical activity

Exclusion Criteria:

1. Diagnosis of diabetes
2. Significant history of chronic disease
3. Evidence of significant liver or kidney disease;
4. Any hormone replacement therapy; and
5. Pregnancy.

Primary outcomes:
measure: Insulin sensitivity index for glucose disposal (ISI [Gly]) during oral glucose tolerance test
timeFrame: At week 9-10 following completion of 8 weeks of intervention period
Secondary outcomes:
measure: index for fat disposal (ISI [FFA]) during oral glucose tolerance test
timeFrame: At week 9-10 following completion of 8 weeks of intervention period
measure: HbA1c
timeFrame: At week 9-10 following completion of 8 weeks of intervention period
measure: Percentage of adiposity (percent body fat)
timeFrame: At week 9-10 following completion of 8 weeks of intervention period
measure: Amino acid concentrations
timeFrame: At week 9-10 following completion of 8 weeks of intervention period
measure: Adiponectin
timeFrame: At week 9-10 following completion of 8 weeks of intervention period
measure: C-reactive protein (CRP)
timeFrame: At week 9-10 following completion of 8 weeks of intervention period
measure: TNF-alpha
timeFrame: At week 9-10 following completion of 8 weeks of intervention period
measure: Interleukin 6 (IL-6)
timeFrame: At week 9-10 following completion of 8 weeks of intervention period
measure: Gene expression levels of critical pathways
timeFrame: At week 9-10 following completion of 8 weeks of intervention period
measure: Total energy expenditure
timeFrame: At week 9-10 following completion of 8 weeks of intervention period
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital / Children's Nutrition Research Center / Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Mustafa Tosur, MD
role: PRINCIPAL_INVESTIGATOR
References: