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Mood and Insulin Resistance in Adolescents At-Risk for Diabetes

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.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

174

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Sundhedsuddannelse
Eksperimentel: Depression Prevention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Insulin Resistance at 12 months in CB depression prevention versus HE control group.

Sekundære resultatmål

Resultatmål
Depressive symptoms at 12 months in CB depression prevention versus HE control group.
CB, depression, prevention, group, will, show, greater, improvements, in, mediators, (eating, behavior, fitness, and stress biomarkers) than the HE control group.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

23. august 2011

Primær færdiggørelse (Faktiske)

10. august 2015

Studieafslutning (Faktiske)

10. august 2015

Datoer for studieregistrering

Først indsendt

27. august 2011

Først indsendt, der opfyldte QC-kriterier

27. august 2011

Først opslået (Skøn)

30. august 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. december 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. december 2019

Sidst verificeret

27. januar 2016

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Depression

Kliniske forsøg med The Blues Program

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Abonner