Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth
調査の概要
詳細な説明
Impaired Glucose Tolerance (IGT) is a prelude to diabetes, which is increasing in prevalence in obese children and adolescents with marked obesity. This condition tends to progress to Type 2 Diabetes Mellitus (T2DM) at an alarmingly rapid tempo. The increased prevalence of childhood and adolescent obesity and greater risk of IGT, and progression to diabetes, in this population set the stage for a series of studies aimed at understanding the metabolic phenotype and natural history of pre-diabetes in obese youth. The investigators found that obese children and adolescents with IGT are characterized by marked insulin resistance related to altered lipid partitioning, favoring lipid deposition in the visceral and intramyocellular compartment. Furthermore, the investigators found an impairment of the acute insulin response in these youngsters. Follow-up revealed a rapid deterioration from IGT to frank diabetes. Based on these studies, there is a strong rationale for changing the balance between visceral and subcutaneous fat and muscle lipid content in a more favorable pattern in order to improve insulin sensitivity.
The primary objective of this study is to determine, in a group of ethnically diverse children and adolescents with IGT, whether treatment with rosiglitazone leads to improvements in insulin sensitivity and glucose tolerance. Secondary objectives are to determine whether rosiglitazone is safe and well tolerated.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Connecticut
-
New Haven、Connecticut、アメリカ、06520
- Yale School of Medicine
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Good general health
- Aged 10 to 18 yrs (females: Tanner stage II-V;and males:testes size>6ml)
- IGT based on 2-hr plasma glucose>140mg/dl and <200mg/dl during an OGTT.
Exclusion Criteria:
- Baseline creatinine>1.0mg
- AST and ALT>2.5 ULN
- Anemia (Hct<30)
- Pregnancy (females must have a negative urine pregnancy test during the study)
- Cardiac or pulmonary or other significant chronic illness
- Plans to increase the frequency or intensity of a regular exercise program
- Psychiatric disorder or substance abuse of anorexic agents.
研究計画
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：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：1
Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan.
Subject then receives Rosiglitazone.
Subjects are followed every 2 weeks.
Imaging repeated at 2 months.
12 week follow up.
And then all tests are repeated at 4 months.
|
2mg to begin then 4mg, twice daily for 4 months
他の名前：
|
|
プラセボコンパレーター：2
Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR.
Subject is randomized (double-blind) to placebo.
Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.
|
Subject receives placebo.
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Percent Change From Baseline in Whole-body Insulin Sensitivity
時間枠：4 months
|
This describes the percent changes in insulin sensitivity.
Insulin sensitivity was expressed as whole body insulin sensitivity index (WBISI) which is based on the values of insulin (microunits per milliliter) and glucose (milligrams per deciliter) obtained from the OGTT and the corresponding fasting values.The formula is: WBISI=10.000/square
root of (fasting glucose x fasting insulin)x(mean glucose x mean insulin).
|
4 months
|
|
Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat
時間枠：4 months
|
This describes the percent changes of the ratio between visceral and subcutaneous abdominal fat.
|
4 months
|
|
Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT)
時間枠：4 months
|
This refers to the number of subjects that converted from IGT to NGT.
NGT is defined as fasting glucose lower than 100 mg/dl and 2 hours glucose lower than 140 mg/dl.
IGT is defined as 2 hours glucose higher than 140 mg/dl.
|
4 months
|
|
Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF)
時間枠：4 months
|
It refers to the percent changes of hepatic fat content.
|
4 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Percent Change From Baseline in Adiponectin
時間枠：4 months
|
This refers to the changes of adiponectin levels.
|
4 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Sonia Caprio, MD、Yale School of Medicine Department of Pediatric Endocrinology
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 0508000532
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。