Dysfunctional Adiposity and Glucose Impairment (DICAMANO)
2018년 4월 24일 업데이트: Clinica Universidad de Navarra, Universidad de Navarra
Discovering Carbohydrate Metabolism Alterations in Normoglycemic Obese Patients Study
This is a large and comprehensively phenotyped cohort with fasting glycaemia where the predictive value of body composition and anthropometric measures of total and central fat distribution for postprandial carbohydrate intolerance are studied.
연구 개요
상세 설명
Subjects aged 18-70 years, who attended the Department of Endocrinology and Nutrition of the Clínica Universidad de Navarra from 2009-2014 for a check-up were offered to participate in the DICAMANO study.
853 subjects agreed to take part.
Only those individuals with a normal fasting glucose level (≤5.5 mmol l-1) were analysed.
Subjects with T2DM or severe renal, liver or thyroid dysfunction were excluded.
Participants were instructed to temporarily discontinue for 48 hours any medication known to affect glucose or lipid metabolism.
On the day of the study visit, each subject had a complete routine clinical assessment to evaluate the presence of cardiovascular, respiratory, renal or endocrine disorders.
All patients underwent a 75-g OGTT with a concomitant anthropometric study, blood pressure monitoring and lipid profile analyses.
They were classified by glucose tolerance on the basis of blood glucose levels according to ADA diagnostic criteria for T2DM (2017).
Carbohydrate intolerance was defined as a 2-hOGTT glucose level ≥7.8 mmol l-1 (mg dl-1).
Body composition, visceral adipose tissue, anthropometry study, OGTT-based parameters and cardiovascular risk factors are measured.
연구 유형
관찰
등록 (실제)
853
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
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
해당 없음
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
Subjects aged 18-70 years, who attended the Department of Endocrinology and Nutrition of the Clínica Universidad de Navarra from 2009-2014 for a check-up were offered to participate in the DICAMANO study
설명
Inclusion Criteria:
- Fasting glucose level ≤ 5.5 mmol l-1
- BMI ≥ 25
Exclusion Criteria:
- Type 2 diabetes mellitus
- Severe renal, liver or thyroid dysfunction
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Body fat percentage and carbohydrate intolerance
기간: Baseline
|
Investigate whether body fat percentage estimated by air-displacement plethysmography (Bod-Pod®, Life Measurements, Concord, CA, USA) predicts postprandial carbohydrate intolerance early on in the metabolic dysregulation process. Body fat percentage (BF%) is calculated from body density by means of the Siri equation. |
Baseline
|
|
Neck circumference as screening tool
기간: Baseline
|
Examine the predictive value of neck circumference as screening tool for the selection of patients who are most likely to benefit from an oral glucose tolerance test (OGTT)
|
Baseline
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Waist-to-hip ratio as screening tool
기간: Baseline
|
Examine the predictive value of waist-to-hip ratio as screening tool for the selection of patients who are most likely to benefit from an oral glucose tolerance test (OGTT).
Waist-to-hip ratio was calculated as waist circumference divided by hip circumference.
Waist circumference was measured at the midpoint between the iliac crest and the rib cage on the mid-axillary line, and hip circumference at the level of the greater trochanters was measured to the nearest millimetre using a flexible tape.
|
Baseline
|
|
Waist-to-height ratio as screening tool
기간: Baseline
|
Examine the predictive value of waist-to-height ratio as screening tool for the selection of patients who are most likely to benefit from an oral glucose tolerance test (OGTT).
Waist-to-height ratio was calculated as waist circumference divided by height.
|
Baseline
|
|
BMI as screening tool
기간: Baseline
|
Examine the predictive value of body adiposity index (BMI) as screening tool for the selection of patients who are most likely to benefit from an oral glucose tolerance test (OGTT).
BMI was calculated as weight in kilograms divided by height in meters squared.
|
Baseline
|
|
Body adiposity index as screening tool
기간: Baseline
|
Examine the predictive value of body adiposity index (BAI) ([hip circumference/height1.5]-18)
as screening tool for the selection of patients who are most likely to benefit from an oral glucose tolerance test (OGTT).
|
Baseline
|
|
Central fat depot and carbohydrate intolerance
기간: Baseline
|
Investigate whether central fat depot predicts postprandial carbohydrate intolerance early on in the metabolic dysregulation process.
Visceral and abdominal adiposity was quantified by the use of the abdominal bioelectrical impedance analysis device ViScan (Tanita AB-140, Tanita Corp., Tokyo, Japan).
|
Baseline
|
|
Central fat depot and cardiometabolic risk
기간: Baseline
|
Investigate whether a higher central fat depot is able to identify those individuals with higher inflammatory parameters (c-reactive protein, homocysteine and uric acid) and cardiovascular risk (higher rate of hypercholesterolemia, hypertension and/or obstructive sleep apnea). Body fat percentage (BF%) is calculated from body density by means of the Siri equation. |
Baseline
|
|
Body fat percentage and cardiometabolic risk
기간: Baseline
|
Investigate whether a higher body fat percentage is able to identify those individuals with higher inflammatory parameters (c-reactive protein, homocysteine and uric acid) and cardiovascular risk (higher rate of hypercholesterolemia, hypertension and/or obstructive sleep apnea). Body fat percentage (BF%) is calculated from body density by means of the Siri equation. |
Baseline
|
|
Prevalence of postprandial carbohydrate intolerance
기간: Baseline
|
Assess the prevalence of postprandial carbohydrate intolerance in individuals with normal fasting glycaemia
|
Baseline
|
|
Oral glucose tolerance test parameters and cardiometabolic profile
기간: Baseline
|
Verification of the utility of the two-hour OGTT glucose value to select those individuals with higher cardiometabolic risk (higher rate of hypercholesterolemia, hypertension and/or obstructive sleep apnea).
|
Baseline
|
|
Non-alcoholic fatty liver disease (NAFLD) and glucose dysregulation
기간: Baseline
|
Analyse the association between NAFLD and OGTT-based ß-cell function and insulin resistance in non-diabetic subjects.
|
Baseline
|
|
OGTT-based indices as screening tool of NAFLD
기간: Baseline
|
Examine whether OGTT-based ß-cell function and insulin resistance indices could be used as screening tools for the selection of patients who are most likely to benefit from a NAFLD-study.
|
Baseline
|
|
OGTT-derived glucose curve as screening tool of NAFLD
기간: Baseline
|
Examine whether the glucose response curve could be used as screening tool for the selection of patients who are most likely to benefit from a NAFLD-study.
|
Baseline
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Gema Frühbeck, PhD, Clinica Universidad de Navarra
- 수석 연구원: Belén Pérez Pevida, MD, Clinica Universidad de Navarra
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 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 (실제)
2009년 1월 29일
기본 완료 (실제)
2014년 8월 28일
연구 완료 (실제)
2016년 1월 28일
연구 등록 날짜
최초 제출
2018년 2월 6일
QC 기준을 충족하는 최초 제출
2018년 4월 23일
처음 게시됨 (실제)
2018년 4월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 4월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 4월 24일
마지막으로 확인됨
2018년 2월 1일
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. .