Study About High Fat Meal and Postprandial Lipemia

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: High fat meal

• Registration Number: NCT01692327
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-25
• Primary Completion: 2012-12
• Study Completion: 2014-07
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-04
• Last Update Posted: 2014-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obese Group	High fat meal	Obese group with fat overload intake.
Glucose Intolerance	High fat meal	glucose intolerance + fat overload intake
Control Group	High fat meal	Control Group + fat overload intake

Primary Outcome Measures

Name	Time	Method
Microvascular function	up to 180 minutes after high fat meal

Secondary Outcome Measures

Name	Time	Method
incretins hormones	basal, 30, 60, 120,180 minutes after high fat meal	We will assess incretins hormones by multiplex

Trial Locations

Locations (1)

Rio de Janeiro State University; 🇧🇷 Rio de janeiro, Brazil