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Dysfunctional Adiposity and Glucose Impairment (DICAMANO)

24 april 2018 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

853

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

N/A

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

Inclusion Criteria:

  • Fasting glucose level ≤ 5.5 mmol l-1
  • BMI ≥ 25

Exclusion Criteria:

  • Type 2 diabetes mellitus
  • Severe renal, liver or thyroid dysfunction

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Body fat percentage and carbohydrate intolerance
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Waist-to-hip ratio as screening tool
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline
Assess the prevalence of postprandial carbohydrate intolerance in individuals with normal fasting glycaemia
Baseline
Oral glucose tolerance test parameters and cardiometabolic profile
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Samarbetspartners

Instituto de Salud Carlos III

Utredare

  • Studiestol: Gema Frühbeck, PhD, Clinica Universidad de Navarra
  • Huvudutredare: Belén Pérez Pevida, MD, Clinica Universidad de Navarra

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

29 januari 2009

Primärt slutförande (Faktisk)

28 augusti 2014

Avslutad studie (Faktisk)

28 januari 2016

Studieregistreringsdatum

Först inskickad

6 februari 2018

Först inskickad som uppfyllde QC-kriterierna

23 april 2018

Första postat (Faktisk)

24 april 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 april 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 april 2018

Senast verifierad

1 februari 2018

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 167/2016

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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