Mood and Insulin Resistance in Adolescents At-Risk for Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Depression, Endocrine |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 12 - 17 |
| Updated: | 3/31/2019 |
| Start Date: | August 23, 2011 |
| End Date: | August 10, 2015 |
Background:
Type 2 diabetes is a chronic disease that puts individuals at risk for serious health
problems like heart disease, kidney failure, vision problems, and stroke. A major way that
type 2 diabetes occurs is through insulin resistance. Insulin resistance means that insulin
(an important hormone in the body to keep blood sugar normal) isn t working as well as it
should, which can lead to problems with high blood sugar. Insulin resistance has been linked
to mood problems, stress, and depression, especially in women. To determine if group programs
can help reduce the risk for type 2 diabetes, researchers want to look at teenage girls who
are at risk for developing the disease.
Objectives:
To test whether a group program designed to improve mood also can help improve insulin
resistance in teenage girls who are at risk for developing type 2 diabetes, or whether a
group program that teaches healthy living skills is just as helpful.
Eligibility:
Teenage girls between 12 and 17 years of age who are at risk for developing type 2 diabetes.
Design:
- Participants will have two screening visits to find out if they are eligible to take
part in the study. The first visit takes about 3 hours and will involve a physical exam,
medical history, questionnaires and an interview about mood problems and possible
depression. The second visit takes about 6 hours and will involve a full body scan to
measure muscle and fat, blood draws and a glucose test to determine insulin resistance,
questionnaires about general well-being and eating habits, eating meals and snacks, and
an exercise test.
- Participants will join one of two group programs at the National Institutes of Health.
One group focuses on learning skills to help with bad moods and stress. The other group
covers topics that are important for teens to lead a healthy life. The groups will meet
for 1 hour once a week for 6 weeks during after-school hours.
- At the end of the groups, participants will have three follow-up visits. The first visit
will be 6 weeks later, the second will be 6 months after the start of the group program,
and the third will be 1 year after the start of the group program. Each visit will take
about 6 hours. These visits are similar to the second screening visit before the groups.
- Some participants will have extra tests to study stress at the second screening visit
and the 6-week, 6-month, and 12-month follow-up visits. Participants will give samples
of DNA, saliva to measure stress hormones, and they will take part in a brief stress
test.
For more information, visit the study website at: http://mir.nichd.nih.gov or contact the
research coordinators for the study at 301-594-3198.
Type 2 diabetes is a chronic disease that puts individuals at risk for serious health
problems like heart disease, kidney failure, vision problems, and stroke. A major way that
type 2 diabetes occurs is through insulin resistance. Insulin resistance means that insulin
(an important hormone in the body to keep blood sugar normal) isn t working as well as it
should, which can lead to problems with high blood sugar. Insulin resistance has been linked
to mood problems, stress, and depression, especially in women. To determine if group programs
can help reduce the risk for type 2 diabetes, researchers want to look at teenage girls who
are at risk for developing the disease.
Objectives:
To test whether a group program designed to improve mood also can help improve insulin
resistance in teenage girls who are at risk for developing type 2 diabetes, or whether a
group program that teaches healthy living skills is just as helpful.
Eligibility:
Teenage girls between 12 and 17 years of age who are at risk for developing type 2 diabetes.
Design:
- Participants will have two screening visits to find out if they are eligible to take
part in the study. The first visit takes about 3 hours and will involve a physical exam,
medical history, questionnaires and an interview about mood problems and possible
depression. The second visit takes about 6 hours and will involve a full body scan to
measure muscle and fat, blood draws and a glucose test to determine insulin resistance,
questionnaires about general well-being and eating habits, eating meals and snacks, and
an exercise test.
- Participants will join one of two group programs at the National Institutes of Health.
One group focuses on learning skills to help with bad moods and stress. The other group
covers topics that are important for teens to lead a healthy life. The groups will meet
for 1 hour once a week for 6 weeks during after-school hours.
- At the end of the groups, participants will have three follow-up visits. The first visit
will be 6 weeks later, the second will be 6 months after the start of the group program,
and the third will be 1 year after the start of the group program. Each visit will take
about 6 hours. These visits are similar to the second screening visit before the groups.
- Some participants will have extra tests to study stress at the second screening visit
and the 6-week, 6-month, and 12-month follow-up visits. Participants will give samples
of DNA, saliva to measure stress hormones, and they will take part in a brief stress
test.
For more information, visit the study website at: http://mir.nichd.nih.gov or contact the
research coordinators for the study at 301-594-3198.
The alarming rise in prevalence of type 2 diabetes (T2D) among adolescents and young adults
poses an enormous public health burden. Insulin resistance (IR) is a major physiological
precursor to T2D. Depressive symptoms are associated with IR in adolescents and adults,
predict adult-onset T2D, and contribute to increased risk for T2D mortality and morbidity.
Depressive symptoms theoretically induce IR by promoting stress-induced behaviors (altered
eating, lowered fitness) and upregulating physiological stress mechanisms (cortisol, NPY).
Psychotherapy for depression improves IR in adults, but it is unknown if ameliorating
depressive symptoms prevents progression of IR in adolescents at risk for T2D. The aims of
this protocol are: 1) to assess the effects of a 6-week cognitive-behavioral (CB) depression
prevention group (the Blues Program) vs. a 6-week standard-of-care health education (HE)
group on reducing depressive symptoms and improving IR in adolescent girls at risk for T2D;
2) to assess the stress-related behavioral and physiological factors that mediate the
relationship underlying decreases in depressive symptoms and improvements in IR; and 3) to
test if genotypic variation in NPY is related to severity of depressive symptoms and IR and
moderates the efficacy of the CB intervention. The proposed study will permit a rigorous test
of the degree to which depressive symptoms contribute to IR. The Blues Program is brief,
easy-to-administer, cost-effective, and efficacious for reducing depressive symptoms among
adolescent girls. If the Blues Program also improves IR, it would have the potential to have
a major impact on T2D prevention in a considerable subset of youth.
poses an enormous public health burden. Insulin resistance (IR) is a major physiological
precursor to T2D. Depressive symptoms are associated with IR in adolescents and adults,
predict adult-onset T2D, and contribute to increased risk for T2D mortality and morbidity.
Depressive symptoms theoretically induce IR by promoting stress-induced behaviors (altered
eating, lowered fitness) and upregulating physiological stress mechanisms (cortisol, NPY).
Psychotherapy for depression improves IR in adults, but it is unknown if ameliorating
depressive symptoms prevents progression of IR in adolescents at risk for T2D. The aims of
this protocol are: 1) to assess the effects of a 6-week cognitive-behavioral (CB) depression
prevention group (the Blues Program) vs. a 6-week standard-of-care health education (HE)
group on reducing depressive symptoms and improving IR in adolescent girls at risk for T2D;
2) to assess the stress-related behavioral and physiological factors that mediate the
relationship underlying decreases in depressive symptoms and improvements in IR; and 3) to
test if genotypic variation in NPY is related to severity of depressive symptoms and IR and
moderates the efficacy of the CB intervention. The proposed study will permit a rigorous test
of the degree to which depressive symptoms contribute to IR. The Blues Program is brief,
easy-to-administer, cost-effective, and efficacious for reducing depressive symptoms among
adolescent girls. If the Blues Program also improves IR, it would have the potential to have
a major impact on T2D prevention in a considerable subset of youth.
- INCLUSION CRITERIA:
- Age 12-17 years
- Female
- BMI greater than or equal to 85th percentile for age.
- CES-D greater than or equal to 16
- Good general health
- T2D or prediabetes (impaired fasting glucose greater than or equal to 100 mg/dL or
impaired glucose tolerance: 2h glucose tolerance test glucose greater than or equal to
140 mg/dL) family history in a first- or second- degree relative.
- English-speaking
EXCLUSION CRITERIA:
- Current major depressive episode
- Current psychiatric symptoms requiring treatment
- Fasting glucose >126 mg/dL
- 2-hour OGTT glucose >200 mg/dL
- Pregnancy
- Use of medication affecting IR, weight, or mood
- Current psychotherapy or weight loss treatment
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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