Prediabetes
Conditions
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.
Interventions
BEHAVIORAL≥10,000 daily steps (≥5 days/week) and stopping evening snacking
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.
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin sensitivity index for glucose disposal (ISI [Gly]) during oral glucose tolerance test | At week 9-10 following completion of 8 weeks of intervention period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| index for fat disposal (ISI [FFA]) during oral glucose tolerance test | At week 9-10 following completion of 8 weeks of intervention period | Insulin sensitivity index for fat disposal (ISI \[FFA\]) will be calculated with a formula using insulin and free fatty acid area under the curves during oral glucose tolerance tests (OGTT) as described previously (Belfiore et al., Metabolism, 2001): ISI (FFA) = 2 / \[INSp x FFAp) + 1\] INSp: insulinemic area during OGTT with 3 (0, 1h and 2h) or 5 sampling (0, 30, 60, 90 and 120 min) FFAp: glycemic area during OGTT (0, 1h and 2h) or 5 sampling (0, 30, 60, 90 and 120 min) INSp and FFAp 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 FFAp) 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. |
| HbA1c | At week 9-10 following completion of 8 weeks of intervention period | Hemoglobin A1c (HbA1c) as measured in the plasma. |
| Percentage of adiposity (percent body fat) | At week 9-10 following completion of 8 weeks of intervention period | Percent body fat as measured by DXA scan |
| Amino acid concentrations | At week 9-10 following completion of 8 weeks of intervention period | Fasting amino acid concentrations as measured in the plasma |
| Adiponectin | At week 9-10 following completion of 8 weeks of intervention period | Fasting adiponectin concentration as measured in the plasma |
| C-reactive protein (CRP) | At week 9-10 following completion of 8 weeks of intervention period | CRP concentration as measured in the plasma |
| TNF-alpha | At week 9-10 following completion of 8 weeks of intervention period | TNF-alpha concentrations as measured in the plasma |
| Interleukin 6 (IL-6) | At week 9-10 following completion of 8 weeks of intervention period | IL-6 level as measured in the plasma |
| Gene expression levels of critical pathways | At week 9-10 following completion of 8 weeks of intervention period | RNA sequencing for gene expression levels of critical metabolic pathways |
| Total energy expenditure | At week 9-10 following completion of 8 weeks of intervention period | In a subset of cohort (n=20), free-living total energy expenditure (TEE) will be measured by the doubly labeled water (DLW) over a 14-d period using multiple urine collections at different time points. This optional part will be offered to all participants, and similar number of participants will be selected randomly from both arms (intervention and standard of care arm) by balancing gender and age categories. |
Countries
United States
Contacts
CONTACTMustafa Tosur, MD
CONTACTLori Malone
PRINCIPAL_INVESTIGATORMustafa Tosur, MD
Baylor College of Medicine
Outcome results
None listed