About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
12-18 years of age
Having a diagnosis of prediabetes
Engaging in frequent evening snacking
Inadequate physical activity
Disqualifiers
Diagnosis of diabetes
Significant history of chronic disease
Evidence of significant liver or kidney disease;
Any hormone replacement therapy; and
Trial design
Parallel
Treatments tested in this trial
≥10,000 daily steps (≥5 days/week) and stopping evening snacking
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
index for fat disposal (ISI [FFA]) during oral glucose tolerance test
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
Hemoglobin A1c (HbA1c) as measured in the plasma.
Percentage of adiposity (percent body fat)
Percent body fat as measured by DXA scan
Amino acid concentrations
Fasting amino acid concentrations as measured in the plasma
Sponsors and contacts
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