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Strength Training and Nutrition Development for African American Youth (STAND)

2017年3月29日 更新者:Michael I. Goran、University of Southern California

USC Center for Transdisciplinary Research on Energetics and Cancer or Obesity-Related Metabolic Disease Risk: Response to Exercise in Minority Youth

The investigators are conducting an intervention study to examine the effects of a 16-week exercise and diet interventions on prevention of disease, specifically type 2 diabetes and heart disease, in African American youth. Sixty overweight African American boys and girls will be recruited and placed in one of the following intervention groups: 1) Control Group (delayed intervention), 2) Dietary Education Group (nutrition education focused on reducing sugar & soda, increased fiber & whole grain intake), or 3) Combination of Strength Training (twice/week for 60 min, progressive increases in exercise volume and intensity) + Dietary Education (nutrition education focused on reducing sugar & soda, increased fiber & whole grain intake). The investigators will assess which intervention group has the most effects on health parameters such as weight, body composition, and insulin related measures.

調査の概要

詳細な説明

A.1 Aims

The overall goal of this project is to examine role of strength training as a therapeutic intervention to improve the cancer and obesity-related metabolic risk profile in African-American adolescents. The project is prompted by the urgent public health need to prevent and treat cancer and obesity-related problems, including diabetes and cardiovascular disease, in African-American adolescents, a population that is understudied and medically under-served in the Los Angeles area. A recent report from the Institute of Medicine underscored this major public health concern in the childhood obesity field:

"Children's health has made tremendous strides over the past century. In general, life expectancy has increased by more than thirty years since 1900 and much of this improvement is due to the reduction of infant and early childhood mortality. Given this trajectory toward a healthier childhood, the investigators begin the 21st century with a shocking development - an epidemic of obesity in children and youth. The increased number of obese children throughout the US during the past 25 years has led policymakers to rank it as one of the most critical public health threats of the 21st century. (92)" Obesity and metabolic syndrome problems disproportionately affect African-American adolescents (51). This project will explore why African-Americans have greater cancer risk than Hispanics (91), despite a reduced prevalence of the metabolic syndrome (7, 62).

Preliminary work from this laboratory has shown that both African-American and Hispanic children are more insulin resistant than Caucasian children, and this difference is apparently not explained by differences in body fatness. Moreover, the metabolic compensation to a similar degree of insulin resistance markedly differs between African-American and Hispanic children (62). African-Americans display greater hyperinsulinemia in response to a glucose challenge, whereas Hispanics have a more subdued increase in insulin levels due to an increase in second phase insulin secretion. The investigators will have the opportunity to build upon this preliminary work to examine the effects of resistance training on three factors predictive of cancer and metabolic disease risk: 1) body fat distribution; 2) insulin resistance and 3) measures of oxidative stress in African America adolescents. The investigators previously studying Hispanic adolescents in a parallel protocol.

The overall hypotheses of this project are that: (1) hyperinsulinemia in overweight African-American youth is associated with increased long-term cancer risk; and (2) insulin resistance, obesity and oxidative stress in overweight African-American youth will be improved with chronic resistance training and a modified carbohydrate dietary approach. The investigators will specifically examine the following metabolic outcomes, because they have been hypothesized to contribute to the obesity-related increase in cancer and metabolic disease risk:

  • Insulin concentrations and insulin sensitivity;
  • Total body fat, abdominal visceral fat, muscle fat and liver fat;
  • Circulating adipocytokines;
  • Intima-media thickness of the carotid artery
  • Markers of oxidative stress, including: F2-isoprostanes, malondialdehyde (MDA), myeloperoxidase (MPO), oxygen radical absorbance capacity and ROS detection by flow cytometry.

A.2 Aims

The specific aims and hypotheses of project 1 are as follows:

Study 1: Cross-Sectional Measures Specific Aim 1 (Body Fat Compartments): To determine the association of visceral fat, muscle and liver fat and plasma adipocytokines to variation in insulin resistance in African-American youth.

  • Hypothesis 1: Visceral fat, muscle and liver fat, and adipokines will independently contribute to greater insulin resistance.

    • Specific Aim 2 (Insulin Resistance): To examine metabolic compensation to insulin resistance in African-American youth.

  • Hypothesis 2: Insulin resistant African-American youth will exhibit a higher acute insulin response to glucose.

    • Specific Aim 3 (Oxidative Stress): To examine the influence of body fat and insulin resistance on markers of oxidative stress and markers of metabolic disease risk.

  • Hypothesis 3: Increased total body fat and insulin resistance will be associated with greater oxidative stress. The increased oxidative stress will be correlated with the higher acute insulin response.

Study 2 (Randomized Trial of Modification of Carbohydrate Intake and Strength Training) • Specific Aim 4 (Linkage of factors in Aims 1-3): To determine the effects of a randomized modification of carbohydrate intake, and/or strength training intervention in overweight African-American adolescents on potential factors linking obesity, insulin resistance, and oxidative stress.

- Hypothesis 4: Strength training will improve metabolic factors for cancer risk. That is, resistance training will reduce visceral fat; increase insulin sensitivity, reduce hyperinsulinemia, and reduce oxidative stress. The decreases in total body fat and visceral adipose tissue will be associated with improved insulin sensitivity and oxidative stress.

研究の種類

介入

入学 (実際)

62

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • California
      • Los Angeles、California、アメリカ、90033
        • Veronica Atkins Lifestyle Intervention Laboratory

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

14年~18年 (子、大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Overweight (≥85th BMI percentile)
  • African American: Children will initially be defined as African American if they and both parents and all 4 grandparents self identify as African American.

Exclusion Criteria:

  • Diabetes: Children will not be eligible for participation if they have any diagnostic criteria for diabetes, including polyuria, polydipsia with or without unexplained weight loss, fasting plasma glucose >126 mg/dl, or a 2-hour plasma glucose >200 mg/dL during an OGTT using a dose of 1.75g glucose/kg BW (to a maximum of 75g). Children will also be excluded if they test positive for diabetes-related auto-antibodies, including ICA512 and GAD. Children testing positive for type 2 diabetes will be referred for treatment. Children with impaired glucose tolerance (fasting glucose >100 mg/dL or 2-hour glucose >140 mg/dl during an oral glucose tolerance test) and/or conditions associated with insulin resistance (e.g. acanthosis nigricans, hypertension, dyslipidemia, poly-cystic ovarian syndrome) will be eligible, as long as they are not receiving treatment and meet other eligibility criteria.
  • Weight loss or exercise program: currently involved with any weight loss or exercise program, or have been in the 6 months prior to participation
  • Use of medications: taking any medications known to influence body composition or insulin action/secretion (e.g. prednisone, ritalin, growth hormone)
  • Syndromes that influence body composition: diagnosed with syndromes or diseases that may influence body composition and fat distribution (e.g. Cushing syndrome, Down syndrome)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:階乗代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
介入なし:コントロール(C)
実験的:Nutrition (N)
Nutrition classes for 1 hour & 30 minutes once a week for 16 weeks + motivational interviewing (4 individual sessions)
実験的:Strength Training & Nutrition (ST)
Strength Training twice a week for 1 hour a day for 16 weeks + Nutrition once a week for 1 hour & 30 minutes for 16 weeks + motivational interviewing (4 individual & 4 group sessions)

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
insulin sensitivity
時間枠:post interventive (week 16)
post interventive (week 16)

二次結果の測定

結果測定
時間枠
adiposity
時間枠:post intervention (week 16)
post intervention (week 16)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2007年6月1日

一次修了 (実際)

2008年11月1日

研究の完了 (実際)

2008年12月1日

試験登録日

最初に提出

2011年9月23日

QC基準を満たした最初の提出物

2011年9月26日

最初の投稿 (見積もり)

2011年9月27日

学習記録の更新

投稿された最後の更新 (実際)

2017年3月31日

QC基準を満たした最後の更新が送信されました

2017年3月29日

最終確認日

2017年3月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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