Study About High Fat Meal and Postprandial Lipemia

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692327
• Other study ID #: Biovasc-02
• Secondary ID: Biovasc002
• Status: Completed
• Phase: N/A
• First received: September 12, 2012
• Last updated: November 4, 2014
• Start date: September 2012
• Est. completion date: July 2014

Study information

• Verified date: November 2014
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• High fat meal

Locations

Country	Name	City	State
Brazil	Rio de Janeiro State University	Rio de janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Rio de Janeiro State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microvascular function		up to 180 minutes after high fat meal	Yes
Secondary	incretins hormones	We will assess incretins hormones by multiplex	basal, 30, 60, 120,180 minutes after high fat meal	Yes