Adipokines in Obese Adolescents With Insulin Resistance
2012년 4월 23일 업데이트: Maria Lola Evia-Viscarra, Hospital Regional de Alta Especialidad del Bajio
Inflammatory Mediators in Obese Adolescents With Insulin Resistance Following Metformin Treatment: Controlled Randomized Clinical Trial
The purpose of this study is to compare serum concentrations of inflammatory cytokines, interleukin 6 (IL-6), High-sensitivity C-reactive protein (hs-CRP), adiponectin, and tumour necrosis factor alpha (TNFα), before and after three months treatment with metformin in obese adolescents with insulin resistance (IR).
연구 개요
상세 설명
The increased prevalence of obesity in pediatric patients is a public health problem particularly because of the difficulties involved with changing lifestyles. Current studies of obese children and adolescents show increased insulin resistance (IR) and chronic inflammatory states. These conditions increase the risk of disability and/or premature death.
The current treatment schemes for obese children are conservative and are focused on changing their lifestyles (exercise and dietary plans). However, metabolic conditions, such as IR, dyslipidemia, and inflammatory processes, are perpetuated.
Metformin is a biguanide that is used for adolescents with diabetes mellitus and polycystic ovarian syndrome. Several clinical trials with metformin for obese pediatric patients have observed decreases in IR, decreases in weight, and improvements in lipid metabolism.
Adipose tissue is not only an energy repository, but also plays an immunological role by the secretion of cytokines. Both overweight adults and adolescents show decreases in adiponectin levels and increases in tumor necrosis factor alpha (TNFα) and interleukin 6 (IL-6). IL-6 can stimulate the production of high-sensitivity C-reactive protein (hs-CRP), which is considered to be a risk marker for the development of cardiovascular disease.
연구 유형
중재적
등록 (실제)
31
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Distrito Federal
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México, Distrito Federal, 멕시코, 06720
- Hospital Infantil de Mexico Federico Gomez
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Guanajuato
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León, Guanajuato, 멕시코, 37670
- Hospital Regional de Alta Especialidad del Bajio
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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
9년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Obesity defined as Body Mass Index (BMI) ≥ percentile 95
- Tanner stage ≥ 2
- Insulin resistance defined as Basal insulin > 15 µU/mL or Homeostasis Model Assessment index (HOMA) > 4.5
- Patients' parents signed written consents when they and their adolescent children agreed to enroll
Exclusion Criteria:
- Glucose intolerance
- Diabetes mellitus (type 1 or 2)
- Anemia (Hb < 10 g/dL)
- Plasma creatinine > 1.4 mg/dL
- Abnormal hepatic function
- Any associated Disease (Pulmonary, Infection, Autoimmune Disease)
- History of lactic acidosis
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: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Metformin
Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
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Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
다른 이름들:
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위약 비교기: Placebo
Tablet of 500 mg oral placebo every 12 hours for 3 months.
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Tablet of 500 mg oral placebo every 12 hours for 3 months.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Adiponectin
기간: baseline and 3 months
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Change from baseline in Adiponectin after 3 months of treatment.
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baseline and 3 months
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High-sensitivity C-reactive Protein
기간: baseline and 3 months
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Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment.
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baseline and 3 months
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Interleukin 6
기간: baseline and 3 months
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Change from baseline in Interleukin 6 after 3 months of treatment.
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baseline and 3 months
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Tumour Necrosis Factor Alpha
기간: baseline and 3 months
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Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.
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baseline and 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Fasting Plasma Glucose
기간: baseline and 3 months
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Change from baseline in Fasting plasma glucose after 3 months of treatment.
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baseline and 3 months
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Fasting Insulin
기간: baseline and 3 months
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Change from baseline in Fasting insulin after 3 months of treatment.
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baseline and 3 months
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Body Mass Index
기간: baseline and 3 months
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Change from baseline in Body Mass Index after 3 months of treatment.
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baseline and 3 months
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Waist Circumference
기간: baseline and 3 months
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Change from baseline in Waist circumference after 3 months of treatment.
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baseline and 3 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Maria L Evia-Viscarra, M.D., Hospital Regional de Alta Especialidad del Bajio
- 연구 의자: Edel R Rodea-Montero, Statistician, Hospital Regional de Alta Especialidad del Bajio
- 연구 의자: Evelia Apolinar-Jiménez, Nutrition, Hospital Regional de Alta Especialidad del Bajio
- 연구 의자: Leticia M García-Morales, M.D., Hospital Infantil de Mexico Federico Gomez
- 연구 의자: Constanza Leaños-Pérez, M.D., Hospital Infantil de Mexico Federico Gomez
- 연구 의자: Mireya Figueroa-Barrón, Chemestry, Hospital Infantil de Mexico Federico Gomez
- 연구 의자: Dolores Sánchez-Fierros, Chemestry, Hospital Infantil de Mexico Federico Gomez
- 연구 의자: Nathalie Muñoz-Noriega, Nutrition, Hospital Regional de Alta Especialidad del Bajio
- 연구 의자: Juan G Reyes-García, M.D., Escuela Superior de Medicina del IPN
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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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
2007년 1월 1일
기본 완료 (실제)
2009년 12월 1일
연구 완료 (실제)
2010년 3월 1일
연구 등록 날짜
최초 제출
2011년 8월 4일
QC 기준을 충족하는 최초 제출
2011년 8월 4일
처음 게시됨 (추정)
2011년 8월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 4월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 4월 23일
마지막으로 확인됨
2012년 4월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 010-08
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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