- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07567287
A Study Using Human Abdominal Adipose Tissue Biopsies to Characterize the Role of Endocannabinoids in Adipocyte Differentiation (ECTADIF)
A Basic Study Using Human Abdominal Adipose Tissue Biopsies to Characterize the Role of Endocannabinoids in Adipocyte Differentiation
Abdominal obesity and type 2 diabetes are associated with hyperactivation of the endocannabinoid system. Several animal and human studies indicate that circulating endocannabinoid levels correlate with body fat mass. Thus, adipose tissue, which possesses the enzymatic machinery of the endocannabinoid system, may be the primary producer of plasma endocannabinoids.
Today, it is well established that stimulation of the endocannabinoid system, through the activation of cannabinoid receptor 1 (CB1R) located in the brain, leads to increased food intake and weight gain. Furthermore, peripheral CB1R present in adipose tissue are also directly involved in energy storage processes. Indeed, activation of the endocannabinoid system in adipose tissue is associated with stimulation of pathways leading to the uptake of carbohydrates and fatty acids, as well as their storage in the form of triglycerides.
Adipose tissue consists primarily of mature adipocytes, and activation of the endocannabinoid system appears to play a key role in increasing fat mass by promoting the hypertrophy of these adipocytes through the stimulation of lipogenesis. However, the vascular stromal fraction also contains stem cells capable of generating new adipocytes, and an autocrine action of endocannabinoids on progenitor cells could also contribute to its expansion by promoting hyperplasia.
That is why, in this project, the investigators aim to study the impact of endocannabinoids on the differentiation of stem cells from the stromal-vascular fraction into adipocytes. In particular, the investigators will seek to compare the impact of endocannabinoids on the differentiation capacity of stem cells derived from adipose tissue collected from patients with obesity, with or without diabetes, compared to controls.
These data, combined with those obtained in parallel in mice, could help determine whether adipose tissue (visceral and/or subcutaneous) is a priority target for the development of CB1R-blocking molecules (such as rimonabant) with exclusively peripheral action (which do not cross the blood-brain barrier to avoid psychiatric side effects) for the treatment of metabolic obesity and type 2 diabetes.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Bruno VERGES
- 전화번호: +33 03.80.29.38.54
- 이메일: bruno.verges@chu-dijon.fr
연구 장소
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Dijon, 프랑스
- Chu Dijon Bourgogne
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연락하다:
- Bruno VERGES
- 전화번호: +33 03.80.29.38.54
- 이메일: bruno.verges@chu-dijon.fr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Control group :
- Men or postmenopausal women aged 18 to 80
- Individuals who have provided their free and informed written consent
- Individuals scheduled to undergo abdominal surgery
Non-diabetic obese individuals :
- Men or postmenopausal women aged 18 to 80
- BMI > 30 - Individuals who have provided written, free, and informed consent
- Scheduled to undergo abdominal surgery
Obese individuals with diabetes :
- Men or postmenopausal women aged 18 to 80 with type 2 diabetes not treated with insulin or a GLP-1 agonist
- BMI > 30
- Individuals who have provided written, free, and informed consent and are scheduled to undergo abdominal surgery
Exclusion Criteria :
Control group :
- Individuals not enrolled in or eligible for a social security program
- Individuals subject to legal guardianship (curatorship, guardianship)
- Individuals subject to judicial protective measures
- Pregnant women, women in labor, or breastfeeding women
- Adults who are legally incapacitated or unable to give consent
- Minors
- BMI > 30
- Diabetes
- Chronic inflammatory disease
- Cancer undergoing chemotherapy or having undergone chemotherapy within the past year
- Gastrointestinal cancer with recent weight loss and/or malnutrition
- Known metastatic cancers
- Cancers undergoing long-term hormonal therapy
- Any positive result for screening for human immunodeficiency virus (HIV) infection, hepatitis B surface antigen testing, or testing for antibodies against the hepatitis C virus (HCV) with a positive HCV RNA test.
Non-diabetic obese individuals :
- Individuals not enrolled in or eligible for a social security program
- Individuals subject to legal guardianship (curatorship, guardianship)
- Individuals subject to judicial protective measures
- Pregnant women, women in labor, or breastfeeding women
- Adults who are legally incapacitated or unable to give consent
- Minors
- Diabetes
- Chronic inflammatory disease
- Cancer undergoing chemotherapy or having undergone chemotherapy within the past year
- Gastrointestinal cancer with recent weight loss and/or malnutrition
- Known metastatic cancers
- Cancers undergoing long-term hormonal therapy,
- Any positive result for screening for human immunodeficiency virus (HIV) infection, hepatitis B surface antigen, or antibodies to hepatitis C virus (HCV) with a positive HCV RNA test.
Obese individuals with diabetes
- Individuals not enrolled in or not eligible for a social security program
- Individuals subject to legal guardianship (curatorship, guardianship)
- Individuals subject to judicial protective measures
- Pregnant women, women in labor, or breastfeeding women
- Adults who are legally incapacitated or unable to give consent
- Minors
- Diabetes
- Chronic inflammatory disease
- Cancer undergoing chemotherapy or having undergone chemotherapy within the past year
- Gastrointestinal cancer with recent weight loss and/or malnutrition
- Known metastatic cancers
- Cancers undergoing long-term hormonal therapy,
- Any positive result for screening for human immunodeficiency virus (HIV) infection, hepatitis B surface antigen, or antibodies against hepatitis C virus (HCV) with a positive HCV RNA test.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: 대조군
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Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.
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다른: Non-diabetic obese individuals
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Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.
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다른: Obese individuals with diabetes
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Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Monitoring the differentiation of stem cells from the stromal-vascular fraction into adipocytes
기간: At baseline, biopsies of visceral and subcutaneous adipose tissue will be performed in the operating room during patients' visceral surgery. The samples will be promptly transferred to the INSERM laboratory for stem cell culture to assess adipocyte diffe
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At baseline, biopsies of visceral and subcutaneous adipose tissue will be performed in the operating room during patients' visceral surgery. The samples will be promptly transferred to the INSERM laboratory for stem cell culture to assess adipocyte diffe
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- VERGES 2025
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
Collection of adipose tissue samples에 대한 임상 시험
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Black Tie Medical, Inc.Robert W. Alexander, MD초대로 등록코로나바이러스 감염 | 특발성 폐 섬유증 | 간질성 폐질환 | COPD | 폐포 단백증 | 바이러스성 폐렴미국