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Completed

NCT Number: NCT01692327

Study About High Fat Meal and Postprandial Lipemia

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.

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Key information

Conditions

Obesity Body Weight Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rio de Janeiro State University

Rio de Janeiro, 20550900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High fat meal

Dietary Supplement

Primary outcomes

  1. Microvascular function

    Time frame: up to 180 minutes after high fat meal

Secondary outcomes

  1. incretins hormones

    Time frame: basal, 30, 60, 120,180 minutes after high fat meal

    We will assess incretins hormones by multiplex

Sponsors and collaborators

Lead sponsor

Rio de Janeiro State University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2014
First posted
Sep 25, 2012
Registry last updated
Nov 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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