Study About High Fat Meal and Postprandial Lipemia

November 4, 2014 updated by: Priscila Alves Maranhao, Rio de Janeiro State University

Evaluating the Effect of Lipid Overload in Endothelial Function and Microvascular Reactivity in Young Obese Women

The hypothesis of the proposed project is that after a fat overload, the postprandial response is different in both groups, suggesting that the LPP will present the most significant damage in endothelial vasomotion in obese individuals, especially those with GI and T2DM. After the fat overload, we hypothesized that there will be a worsening of endothelial function and microvascular reactivity in OB/DM2 and OB group compared to C, but also find lower concentrations of incretins in OB/DM2 group compared to other groups.

These hypotheses may be confirmed by techniques for evaluating microvascular function, the use of DFT skin for vasomotion evaluation and finally analysis of analytes through metabolic and cardiovascular read by Multiplex kit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Will be recruited 60 women aged 19-40 years, with a diagnosis of obesity (BMI ≥ 30 kg/m2) treated at the obesity clinic at the State University of Rio de Janeiro (UERJ)at Brazil.

Microcirculation parameters and blood tests will be assessed at baseline and after this, the women will receive a high-fat meal containing croissant, salami, whole milk and cheddar cheese. After 30, 60, 120 and 180 minutes this meal the microcirculation will be evaluated as well as blood collection.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de janeiro, Brazil, 20550900
        • Rio de Janeiro State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • all patients should have obesity class I (BMI between 30 and 35kg/m2);
  • Submit diabetes mellitus without further treatment or be obese non-diabetic or glucose intolerant;
  • Presenting the age between 19 to 40 years.
  • Waist circumference> 80 cm (IDF)

Exclusion Criteria:

  • Renal disease, coronary or peripheral vascular, hematologic or hepatic impairment;
  • Presence of dyslipidemia;
  • smokers;
  • Significant loss of body weight six months prior to the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Obese Group
Obese group with fat overload intake.
Dietary supplement: High fat meal
Other: Control Group
Control Group + fat overload intake
Dietary supplement: High fat meal
Other: Glucose Intolerance
glucose intolerance + fat overload intake
Dietary supplement: High fat meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Microvascular function
Time Frame: up to 180 minutes after high fat meal
up to 180 minutes after high fat meal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incretins hormones
Time Frame: basal, 30, 60, 120,180 minutes after high fat meal
We will assess incretins hormones by multiplex
basal, 30, 60, 120,180 minutes after high fat meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rio de Janeiro State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

September 24, 2012

First Posted (Estimate)

September 25, 2012

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 4, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Biovasc-02
  • Biovasc002 (Registry Identifier: Over load project)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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