- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00452166
Rosiglitazone and Insulin Resistance in Renally Impaired Patients
30 non-diabetic, non-obese patients with stage 4 chronic kidney disease will be asked to participate in this metabolic study.
The primary aim of this study is to determine the effect of rosiglitazone on insulin resistance in non-obese patients with non-diabetic stage 4 CKD.
Secondary end points are the effects on inflammation (hsCRP), lipid profile, bone density and body composition.
연구 개요
상세 설명
This part of the study will be performed in 30 non-diabetic non-obese patients. In this study patients will receive single-dose oral placebo and rosiglitazone once daily to be taken in the morning. During the first 8 weeks the patients will be dosed with 4 mg rosiglitazone. Then the concentration of the serum transaminases will be checked and if these are within an acceptable range, the doses will be doubled for the remainder of the study. If the changes in serum transaminases are considered clinically significant the patient will be withdrawn from the study and if the transaminases have increased but not to clinically significant level then the treatment of patient may be continued on the 4 mg daily dose.
The insulin sensitivity will be measured by using a euglycaemic hyperinsulinaemic clamp technique, which is validated technique.
Screening of eligible patients: fasting glucose ≤ 7,0 mmol/L and BMI ≤ 30.
Exclusion criteria are:
- A diagnosis of diabetes mellitus for which the patient uses insulin;
- Significant co-morbidities which, according to the treating nephrologists, makes it unlikely that the patient will be able to complete the foreseen study period;
- Significant cardiovascular co-morbidities which are likely to interfere with the objectives of the study (morbid obesity, family history of dyslipidemia, etc.); at the discretion of the treating nephrologists or the principal investigator;
- Allergy for PPAR's;
- Cardiac disease with marked limitation of functional capacity (New York Heart Association III or IV clinical status);
- Use of immunosuppressant agents;
- History of renal transplant;
- Hepatic insufficiency (defined as transaminase concentrations above > 2.5 times the upper limit of normal for the laboratories);
- A history of alcohol abuse or excessive alcohol use defined as more than 21 consumptions per week;
- For female patients: pregnancy, the intention to become pregnant within the study period, or lactating patients Eligible patients will receive insulin (Actrapid; Novo Nordisk A/S, Copenhagen, Denmark) at an infusion rate of 40 mU (288 pmol)/kg/m2 body surface area per minute. Euglycemia (target blood concentration of 5 mM) will be maintained by adjusting the rate of 20% glucose infusion according to whole blood glucose concentration measured from arterialized venous blood; the patient keeps his or her right arm in a box containing heated air (60°C). Insulin and glucose will be infused in the left arm. In healthy subjects, hepatic glucose production is completely suppressed when the serum insulin level is >60 mU/L. Here the expected insulin level in serum is 80 mU/L. Blood samples will be drawn at 5 min intervals for the determination of blood glucose, and at 10 min intervals during the period of 90 -120 min for the determination of serum insulin and free fatty acids. The insulin-sensitivity index (ISI) will be calculated by dividing the average glucose-infusion rate by the mean steady-state serum insulin levels during a period of 90 -120 min. In addition to glucose-infusion rate and insulin sensitivity index, the influence of the clamp on levels of FFA will also be assed.
At baseline and during the follow-up of the study inflammatory parameters (hsCRP) and lipids will be measured. At baseline and at the end a bone densitometry (DEXA) will be performed.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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Leiden, 네덜란드
- LUMC
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- CKD stage 4
- BMI ≤ 30
- Fasting glucose < 7 mmol/l
Exclusion Criteria:
Exclusion of patients will take place in case of:
- A diagnosis of diabetes mellitus for which the patient uses insulin
- Significant co-morbidities which, according to the treating nephrologists, makes it unlikely that the patient will be able to complete the foreseen study period
- Significant cardiovascular co-morbidities which are likely to interfere with the objectives of the study (morbid obesity, family history of dyslipidemia, etc.); at the discretion of the treating nephrologists or the principal investigator
- Allergy for PPAR's
- Cardiac disease with marked limitation of functional capacity (New York Heart Association III or IV clinical status)
- Use of immunosuppressant agents
- History of renal transplant
- Hepatic insufficiency (defined as transaminase concentrations above > 2.5 times the upper limit of normal for the laboratories)
- A history of alcohol abuse or excessive alcohol use defined as more than 21 consumptions per week
- For female patients: pregnancy, the intention to become pregnant within the study period, or lactating patients
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
인슐린 감수성
기간: 12주
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12주
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2차 결과 측정
결과 측정 |
기간 |
---|---|
체성분
기간: 12주
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12주
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지질 프로필
기간: 12주
|
12주
|
inflammation
기간: 12 weeks
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12 weeks
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bone density
기간: 12 weeks
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12 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: andre gaasbeek, md, LUMC Leiden
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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