Study About High Fat Meal and Postprandial Lipemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Rio de Janeiro State University
Sponsor:
Information provided by (Responsible Party):
Priscila Alves Maranhao, Rio de Janeiro State University
ClinicalTrials.gov Identifier:
NCT01692327
First received: September 12, 2012
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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 Intervention
Obesity
Dietary Supplement: High fat meal

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Evaluating the Effect of Lipid Overload in Endothelial Function and Microvascular Reactivity in Young Obese Women

Resource links provided by NLM:


Further study details as provided by Rio de Janeiro State University:

Primary Outcome Measures:
  • Microvascular function [ Time Frame: up to 180 minutes after high fat meal ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • incretins hormones [ Time Frame: basal, 30, 60, 120,180 minutes after high fat meal ] [ Designated as safety issue: Yes ]
    We will assess incretins hormones by multiplex


Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: July 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692327

Contacts
Contact: Priscila Maranhão, Master 55 21 2334-0703 priscilamaranhao@gmail.com

Locations
Brazil
Rio de Janeiro State University Recruiting
Rio de janeiro, Brazil, 20550900
Contact: Priscila Maranhão, Master    55 21 23340703    priscilamaranhao@gmail.com   
Sub-Investigator: Priscila Maranhão, Master         
Sponsors and Collaborators
Rio de Janeiro State University
  More Information

No publications provided

Responsible Party: Priscila Alves Maranhao, Nutricionist, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT01692327     History of Changes
Other Study ID Numbers: Biovasc-02, Biovasc002
Study First Received: September 12, 2012
Last Updated: November 18, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Rio de Janeiro State University:
glucose intolerance (20)
Control (20)

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014