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Study About High Fat Meal and Postprandial Lipemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01692327
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : November 5, 2014
Information provided by (Responsible Party):
Priscila Alves Maranhao, Rio de Janeiro State University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: High fat meal Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Evaluating the Effect of Lipid Overload in Endothelial Function and Microvascular Reactivity in Young Obese Women
Study Start Date : September 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Obese Group
Obese group with fat overload intake.
Dietary Supplement: High fat meal
Control Group
Control Group + fat overload intake
Dietary Supplement: High fat meal
Glucose Intolerance
glucose intolerance + fat overload intake
Dietary Supplement: High fat meal

Primary Outcome Measures :
  1. Microvascular function [ Time Frame: up to 180 minutes after high fat meal ]

Secondary Outcome Measures :
  1. incretins hormones [ Time Frame: basal, 30, 60, 120,180 minutes after high fat meal ]
    We will assess incretins hormones by multiplex

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01692327

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Rio de Janeiro State University
Rio de janeiro, Brazil, 20550900
Sponsors and Collaborators
Rio de Janeiro State University

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Responsible Party: Priscila Alves Maranhao, Nutricionist, Rio de Janeiro State University Identifier: NCT01692327    
Other Study ID Numbers: Biovasc-02
Biovasc002 ( Registry Identifier: Over load project )
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: November 2014
Keywords provided by Priscila Alves Maranhao, Rio de Janeiro State University:
glucose intolerance (20)
Control (20)