Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)(Completed)
2015년 7월 22일 업데이트: 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).
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
64
단계
- 1단계
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
35년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
다른 이름들:
Placebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period
|
|
실험적: 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.
다른 이름들:
Placebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period
|
|
실험적: 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
|
|
실험적: 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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Glucose Tolerance (IGT)
기간: 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)
기간: 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)
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Glucose Tolerant (IGT)
기간: 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)
기간: 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)
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2009년 3월 1일
기본 완료 (실제)
2010년 2월 1일
연구 완료 (실제)
2010년 3월 1일
연구 등록 날짜
최초 제출
2009년 3월 27일
QC 기준을 충족하는 최초 제출
2009년 3월 27일
처음 게시됨 (추정)
2009년 3월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 7월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 7월 22일
마지막으로 확인됨
2015년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 0000-117
- 2009_567
약물 및 장치 정보, 연구 문서
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