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

ConditionPrediabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorBaylor College of Medicine

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • ≥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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Intervention ArmExperimental treatment 1 intervention
Group B: Standard of Care ArmNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
At week 9-10 following completion of 8 weeks of intervention period
2

HbA1c

Hemoglobin A1c (HbA1c) as measured in the plasma.

Time frame
At week 9-10 following completion of 8 weeks of intervention period
3

Percentage of adiposity (percent body fat)

Percent body fat as measured by DXA scan

Time frame
At week 9-10 following completion of 8 weeks of intervention period
4

Amino acid concentrations

Fasting amino acid concentrations as measured in the plasma

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

Other outcomes

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