Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)(Completed)
2015年7月22日 更新者：Merck Sharp & Dohme LLC
A Randomized, Double-Blind, Placebo-Controlled, 2-Part Study to Evaluate the Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis in Obese Patients With Hypertension
This study will measure and compare changes in insulin production and sensitivity using the hyperglycemic clamp technique in obese patients with impaired glucose tolerance and hypertension treated with placebo, isosorbide mononitrate (ISMN) or hydrochlorothiazide (HCTZ).
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
64
段階
- フェーズ 1
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
35年～75年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Female participants must be post-menopausal
- Body Mass Index (BMI) of at least 29 kg/m^2
- Weight has been stable over the past 3 months
- Has never been treated for hypertension or is diagnosed with hypertension taking up to 2 anti-hypertensive medications
- Willing to stop hypertension treatment for 14 days prior to randomization and throughout the study
- Does not have a history of diabetes
- In good health with the exception of hypertension
- No history of abnormal heart rhythms
- Part I only: willing to comply with high potassium/low sodium diet for the duration of the study
- Willing to avoid strenuous physical activity during the study
- Nonsmoker and/or has not used nicotine for at least 3 months and agrees to refrain from use of tobacco-containing products throughout the study
- Agrees to refrain from consuming alcohol and caffeine during in-patient periods and to limit consumption at all other times during the study
- Agrees not to consume grapefruit, grapefruit products, and citrus, apple, and pineapple juices 2 weeks prior to administration of the first dose of study drug
Exclusion Criteria:
- History of any illness that may make their participation in the study unsafe or confuse the study results
- Taking spironolactone or eplerenone
- Cannot refrain from using any prescription or non-prescription drugs during the study
- On a weight loss program and is not in the maintenance phase
- Started a weight loss drug within 8 weeks of the first study visit
- Consumes excessive amounts of alcohol or caffeine
- Has had major surgery, donated or lost 1 unit of blood within 4 weeks of the first study visit
- History of multiple and/or severe allergies to drugs or food
- Is dehydrated
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：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Part I, Placebo-HCTZ
Placebo in Period 1 followed by HCTZ in Period 2
|
HCTZ 50 mg (two 25 mg capsules) once daily for 4 weeks per treatment period.
他の名前：
Placebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period
|
|
実験的：Part I, HCTZ-Placebo
HCTZ in Period 1, followed by placebo in Period 2
|
HCTZ 50 mg (two 25 mg capsules) once daily for 4 weeks per treatment period.
他の名前：
Placebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period
|
|
実験的：Part II, Placebo-ISMN
Placebo in Period 1, followed by ISMN in Period 2
|
ISMN 60 mg extended release capsule once daily for 4 weeks per treatment period
Placebo to ISMN 0 mg capsule once daily for 4 weeks per treatment period
|
|
実験的：Part II, ISMN-Placebo
ISMN in Period 1, followed by placebo in Period 2
|
ISMN 60 mg extended release capsule once daily for 4 weeks per treatment period
Placebo to ISMN 0 mg capsule once daily for 4 weeks per treatment period
|
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 |
|---|---|---|
|
Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Glucose Tolerance (IGT)
時間枠：90 -120 minutes post-dose
|
Steady state was defined as 90-120 minutes post-dose.
IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening.
|
90 -120 minutes post-dose
|
|
Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Fasting Glucose (IFG)
時間枠：90 -120 minutes post-dose
|
Steady state was defined as 90-120 minutes post-dose.
IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening.
|
90 -120 minutes post-dose
|
|
Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants Who Had Normal Glucose Tolerance (NGT)
時間枠：90 -120 minutes post-dose
|
Steady state was defined as 90-120 minutes post-dose.
NGT participants (FPG <100 mg/dL & 2 hour plasma glucose (PG) <140 mg/dL during a 75g oral glucose tolerance test (OGTT) at screening) were neither Impaired Glucose Tolerant (IGT) nor Impaired Fasting Glucose (IFG).
IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening.
IFG was defined as FPG between 100 and 125 mg/dL at screening.
|
90 -120 minutes post-dose
|
|
Part II: Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady-state
時間枠：90 -120 minutes post-dose
|
Steady state was defined as 90-120 minutes post-dose.
The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration.
The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes.
|
90 -120 minutes post-dose
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Glucose Tolerant (IGT)
時間枠：90 -120 minutes post-dose
|
Steady state was defined as 90-120 minutes post-dose.
The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration.
The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes.
IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening.
|
90 -120 minutes post-dose
|
|
Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Fasting Glucose (IFG)
時間枠：90 -120 minutes post-dose
|
Steady state was defined as 90-120 minutes post-dose.
The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration.
The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes.
IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening.
|
90 -120 minutes post-dose
|
|
Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Normal Glucose Tolerant (NGT)
時間枠：90 -120 minutes post-dose
|
Steady state was defined as 90-120 minutes post-dose.
The ratio was the measure of the quantity of glucose disposed per unit of plasma insulin concentration (PIC).
Approximate PIC was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals, time = 90, 100, 110, and 120 minutes.
NGT participants (FPG <100 mg/dL & 2 hour PG <140 mg/dL during a 75g OGTT at screening) were neither IGT nor IFG at screening.
IGT - defined as a 2 hour PG >= 140 and <= 199 mg/dL during a 75g OGTT at screening.
IFG - defined as FPG between 100 and 125 mg/dL at screening.
|
90 -120 minutes post-dose
|
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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。
スポンサー
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
2009年3月1日
一次修了 (実際)
2010年2月1日
研究の完了 (実際)
2010年3月1日
試験登録日
最初に提出
2009年3月27日
QC基準を満たした最初の提出物
2009年3月27日
最初の投稿 (見積もり)
2009年3月30日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年7月28日
QC基準を満たした最後の更新が送信されました
2015年7月22日
最終確認日
2015年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 0000-117
- 2009_567
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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