- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01079845
A Cooking and Eating Study (ACES)
Low-glycemic Load vs. Low-fat Diet for Treating PCOS in Obese Adolescents and Young Adults
Background. The polycystic ovary syndrome (PCOS) is a complex hormonal disorder that presents in susceptible girls around the time of menarche. Females with PCOS have high levels of androgens (e.g., testosterone). While cosmetic appearance (excess facial hair and acne) and menstrual disturbances were once considered the primary concerns, emerging data indicate that many adolescents and young adults with PCOS are insulin resistant and at increased risk for metabolic syndrome and diabetes. The majority of females with PCOS are obese, and excess body fat amplifies the severity of the syndrome.
Dietary intervention is considered an important component of treatment for PCOS. However, a consensus statement regarding optimal nutrient composition for treating adolescents and young adults with PCOS has not been published because data are lacking to provide a foundation for such a statement. Recognizing increased risk for diabetes in patients with PCOS, many practitioners employ a low-fat diet as prescribed in the Diabetes Prevention Program (DPP) for weight loss and control of symptoms.
Objective and Hypothesis. The purpose of this research study is to compare different diets for treating PCOS. We hypothesize that a low-glycemic load diet - designed to lower blood levels of glucose and insulin - will be more beneficial than a low-fat diet in obese adolescents and young adults with PCOS.
Design. We propose a 6-month study in which 50 obese females with PCOS (ages 13 to 21 years) will be assigned to receive one of two dietary treatments, with the goal of retaining 40 participants. Group assignment will be at random. One of the treatments will be a low-glycemic load diet, and the other treatment will be a low-fat diet (modeled after the DPP diet). Participants in both groups will receive individual nutrition education and dietary counseling with a registered dietitian (clinic visits, telephone calls) and cooking workshops with a chef. The purpose of the cooking workshops will be to enhance compliance with diet prescriptions, beyond what can be achieved by nutrition education and dietary counseling in a conventional clinic setting.
The primary outcome will be bioavailable testosterone (form of testosterone that causes symptoms of PCOS). Secondary outcomes will include other blood tests to evaluate further high androgen levels (total testosterone, free testosterone, sex hormone binding globulin, dehydroepiandrosterone sulfate), clinical signs of high androgen levels (excess facial hair, acne), glucose tolerance and risk for diabetes (determined by blood sugar and insulin measurements), risk for cardiovascular disease (based on blood cholesterol and C-reactive protein levels and blood pressure), body fat percentage and distribution (measured using state-of-the-art dual energy x-ray absorptiometry and waist circumference), menstrual cyclicity, and health-related quality of life (evaluated by questionnaire).
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02115
- Children's Hospital Boston
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Diagnosis of PCOS.
- Aged 13 to 21 years (and living at home with a parent, only for those <18 years old).
- Body mass index (BMI) at or above the 85th percentile.
- Access to a working telephone.
- At least one parent willing and able to participate in the intervention, only for those <18 years old.
- Residing in predominately one household (no more than one weekend every two weeks in a secondary household).
- Medical clearance from the physician who is treating PCOS.
Exclusion Criteria:
- Physician diagnosis of a major medical illness or eating disorder.
- Fasting blood glucose at or above 126 mg/dL, indicating diabetes mellitus.
- Chronic use of any medication that may affect study outcomes.
- Current smoking.
- Physical, mental, or cognitive handicaps that prevent participation.
- Sister participating in the study.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Low-glycemic Load Diet
|
Monthly clinic visits with a dietitian, Monthly telephone calls with a dietitian, Three cooking workshops with a chef
|
Comparador Ativo: Low-fat Diet
|
Monthly clinic visits with a dietitian, Monthly telephone calls with a dietitian, Three cooking workshops with a chef
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Bioavailable Testosterone
Prazo: Baseline, 6 months
|
Baseline, 6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Other Biochemical and Clinical Signs of Hyperandrogenism
Prazo: Baseline, 6 months
|
total and free testosterone, sex hormone binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEAS), hirsutism, acne
|
Baseline, 6 months
|
Insulin Sensitivity and Beta-cell Function
Prazo: Baseline, 6 months
|
frequently-sampled oral glucose tolerance test, HbA1c
|
Baseline, 6 months
|
Risk for Cardiovascular Disease
Prazo: Baseline, 6 months
|
serum levels of HDL cholesterol, LDL cholesterol, triglycerides, and C-reactive protein; blood pressure
|
Baseline, 6 months
|
Body Weight and Composition
Prazo: Baseline, 6 months
|
body fat percentage and distribution assessed by dual-energy x-ray absorptiometry (DXA), waist circumference
|
Baseline, 6 months
|
Cyclicity of Menstrual Periods
Prazo: Monthly
|
Monthly
|
|
Quality of Life
Prazo: Baseline, 6 months
|
Questionnaire
|
Baseline, 6 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Cara B. Ebbeling, PhD, MS, Boston Children's Hospital
Publicações e links úteis
Publicações Gerais
- Ebbeling CB, Leidig MM, Feldman HA, Lovesky MM, Ludwig DS. Effects of a low-glycemic load vs low-fat diet in obese young adults: a randomized trial. JAMA. 2007 May 16;297(19):2092-102. doi: 10.1001/jama.297.19.2092. Erratum In: JAMA. 2007 Aug 8;298(6):627.
- Ebbeling CB, Leidig MM, Sinclair KB, Hangen JP, Ludwig DS. A reduced-glycemic load diet in the treatment of adolescent obesity. Arch Pediatr Adolesc Med. 2003 Aug;157(8):773-9. doi: 10.1001/archpedi.157.8.773.
- Palmert MR, Gordon CM, Kartashov AI, Legro RS, Emans SJ, Dunaif A. Screening for abnormal glucose tolerance in adolescents with polycystic ovary syndrome. J Clin Endocrinol Metab. 2002 Mar;87(3):1017-23. doi: 10.1210/jcem.87.3.8305.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 10-02-0069
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .