Depression and Insulin Sensitivity in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- Insulin secretion
研究概览
简要总结
There has been a rise in type 2 diabetes (T2D) rates in adolescents, disproportionately in girls from disadvantaged racial/ethnic groups. This group of girls also is at heightened risk for depression, and depression and T2D are linked. Depressive symptoms are a risk factor for worsening of insulin sensitivity, one if the major precursors to T2D. In preliminary studies, the investigators found that a brief cognitive-behavioral therapy group decreased depressive symptoms and prevented worsening of insulin sensitivity in adolescent girls at-risk for T2D with moderate depressive symptoms. The aims of this study are: 1) to assess the efficacy of a cognitive-behavioral therapy depression group vs. a health education control group for improving insulin sensitivity and preserving insulin secretion in racially/ethnically diverse adolescent girls at-risk for T2D with moderate depressive symptoms over a 1-year follow-up; 2) to evaluate changes in eating, physical activity, and sleep as explanatory and 3) to test changes in cortisol factors as explanatory.
详细描述
There has been rapid escalation of type 2 diabetes (T2D) rates in adolescents. Early-onset T2D (<20y) typically shows a more aggressive course than adult-onset T2D and disproportionately affects girls from disadvantaged, racial/ethnic groups. This group of girls also is at heightened risk for depression, and depression and T2D are linked. Depressive symptoms often manifest in adolescence and are a prospective risk factor for worsening of insulin sensitivity, the major physiological precursor-in combination with deterioration of pancreatic β-cell capacity to secrete insulin-in the path to T2D. The effects of depression on poor insulin sensitivity remain even after accounting for adiposity. In theory, depressive symptoms may worsen insulin sensitivity through stress-induced behaviors (e.g., disinhibited eating, physical inactivity, sleep disturbance) and stress-induced physiological causal mechanisms (e.g., hypercortisolism). The central theme of this study is that intervening to reduce depressive symptoms in adolescents at-risk for T2D may offer an innovative, targeted approach to ameliorate insulin resistance and to, consequently, preserve β-cell function and lessen T2D risk. In preliminary data, the investigators found initial evidence that a 6-week cognitive-behavioral group decreased depressive symptoms and prevented worsening of insulin sensitivity 1 year later in overweight and obese girls with moderate depressive symptoms and a family history of T2D, in comparison to a 6-week health education control group. Directly extending these findings, the primary aims of this study are: 1) to assess the efficacy of a 6-week cognitive-behavioral depression group vs. a 6-week health education control group for improving insulin sensitivity and preserving β-cell function in racially/ethnically diverse adolescent girls at-risk for T2D with moderate depressive symptoms over a 1-year follow-up; 2) to evaluate changes in eating, physical activity, and sleep as behavioral explanatory mediators underlying the relationship between decreases in depressive symptoms and improvements in insulin sensitivity and β-cell function over 1 year and 3) to test changes in cortisol awakening response, diurnal cortisol rhythm, and total daily cortisol output as physiological mechanisms explaining the relationship between decreases in depressive symptoms and improvements in insulin sensitivity and β-cell function over 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Research staff who assess outcomes will be blinded to condition assignment.
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 12-17 years
- •Body mass index (BMI) ≥85th percentile for age & sex
- •Center for Epidemiologic Studies-Depression Scale (CES-D) >20
- •English speaking
- •≥1 first- or second-degree family member with type 2 diabetes (T2D), prediabetes, or gestational diabetes
- •Good general health
排除标准
- •Pregnancy or breastfeeding
- •Type 2 diabetes as indicated by fasting glucose≥126 mg/dL or 2-hour glucose>200 mg/dL or Hba1c>=6.5
- •Medication affecting mood, weight, cortisol, or insulin sensitivity, including insulin sensitizers (e.g., metformin), anti-depressants, and stimulants
- •Major psychiatric disorder that, in the opinion of the investigators, would impede study compliance and necessitate more intensive treatment, including major depressive disorder, bipolar disorder, posttraumatic stress disorder, panic disorder, obsessive-compulsive disorder, schizophrenia, conduct disorder, alcohol and substance abuse, and anorexia/bulimia nervosa
- •Psychotherapy or structured weight loss program
- •Active suicidal ideation or suicidal behavior
结局指标
主要结局
Insulin secretion
时间窗: 1-year
Oral disposition index estimated from 2-hour oral glucose tolerance test
Insulin sensitivity
时间窗: 1-year
Whole body insulin sensitivity index estimated from 2-hour oral glucose tolerance test
Depressive symptoms
时间窗: 1-year
Center for Epidemiologic Studies-Depression Scale (CES-D) total score
次要结局
- Physical inactivity(1-year)
- Sleep(1-year)
- Cortisol diurnal rhythm(1-year)
- Daily cortisol output(1-year)
- Disinhibited eating(1-year)
- Physical activity(1-year)