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Dysfunctional Adiposity and Glucose Impairment (DICAMANO)

24. april 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

853

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body fat percentage and carbohydrate intolerance
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Samarbejdspartnere

Instituto de Salud Carlos III

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. januar 2009

Primær færdiggørelse (Faktiske)

28. august 2014

Studieafslutning (Faktiske)

28. januar 2016

Datoer for studieregistrering

Først indsendt

6. februar 2018

Først indsendt, der opfyldte QC-kriterier

23. april 2018

Først opslået (Faktiske)

24. april 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. april 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. april 2018

Sidst verificeret

1. februar 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 167/2016

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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