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Dysfunctional Adiposity and Glucose Impairment (DICAMANO)

24. april 2018 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

853

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

N/A

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Samarbeidspartnere

Instituto de Salud Carlos III

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. januar 2009

Primær fullføring (Faktiske)

28. august 2014

Studiet fullført (Faktiske)

28. januar 2016

Datoer for studieregistrering

Først innsendt

6. februar 2018

Først innsendt som oppfylte QC-kriteriene

23. april 2018

Først lagt ut (Faktiske)

24. april 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. april 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. april 2018

Sist bekreftet

1. februar 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 167/2016

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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