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Body CompositionDICAMANONCT03506581

Dysfunctional Adiposity and Glucose Impairment

An observational study of Body Composition and Visceral Obesity, run by Clinica Universidad de Navarra, Universidad de Navarra.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
How many people
853 participants
Where
No sites listed yet
Study dates
29 Jan 2009to 28 Jan 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Adult, Older adult

Study population: 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

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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.

Read the detailed description

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.

Medical subject headings
Obesity, Abdominal, Glucose-Galactose Malabsorption, Insulin Resistance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body fat percentage and carbohydrate intolerance

    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.

    Measured: Baseline

  2. Neck circumference as screening tool

    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)

    Measured: Baseline

Secondary outcomes (12)

  1. Waist-to-hip ratio as screening tool

    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.

    Measured: Baseline

  2. Waist-to-height ratio as screening tool

    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.

    Measured: Baseline

  3. BMI as screening tool

    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.

    Measured: Baseline

  4. Body adiposity index as screening tool

    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).

    Measured: Baseline

  5. Central fat depot and carbohydrate intolerance

    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).

    Measured: Baseline

  6. Central fat depot and cardiometabolic risk

    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.

    Measured: Baseline

  7. Body fat percentage and cardiometabolic risk

    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.

    Measured: Baseline

  8. Prevalence of postprandial carbohydrate intolerance

    Assess the prevalence of postprandial carbohydrate intolerance in individuals with normal fasting glycaemia

    Measured: Baseline

  9. Oral glucose tolerance test parameters and cardiometabolic profile

    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).

    Measured: Baseline

  10. Non-alcoholic fatty liver disease (NAFLD) and glucose dysregulation

    Analyse the association between NAFLD and OGTT-based ß-cell function and insulin resistance in non-diabetic subjects.

    Measured: Baseline

  11. OGTT-based indices as screening tool of NAFLD

    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.

    Measured: Baseline

  12. OGTT-derived glucose curve as screening tool of NAFLD

    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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2018
  2. Study start29 Jan 2009
  3. Primary completion28 Aug 2014
  4. Study completion28 Jan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
853 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03506581
Sponsor's protocol ID
167/2016
Acronym
DICAMANO
Status last verified
Feb 2018
First submitted
6 Feb 2018
Last updated
25 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Perez-Pevida B, Nunez-Cordoba JM, Romero S, Miras AD, Ibanez P, Vila N, Margall MA, Silva C, Salvador J, Fruhbeck G, Escalada J. Discriminatory ability of anthropometric measurements of central fat distribution for prediction of post-prandial hyperglycaemia in patients with normal fasting glucose: the DICAMANO Study. J Transl Med. 2019 Feb 18;17(1):48. doi: 10.1186/s12967-019-1787-5.

    PubMed 30777085

Questions about this trial

What is this clinical trial studying?

An observational study of Body Composition and Visceral Obesity, run by Clinica Universidad de Navarra, Universidad de Navarra.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body fat percentage and carbohydrate intolerance (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03506581, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018.

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Dysfunctional Adiposity and Glucose Impairment | AzTrials