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Study About High Fat Meal and Postprandial Lipemia

R

Rio de Janeiro State University

Status

Completed

Conditions

Obesity

Treatments

Dietary Supplement: High fat meal

Study type

Interventional

Funder types

Other

Identifiers

NCT01692327
Biovasc-02
Biovasc002 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

Female

Ages

19 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 3 patient groups

Obese Group
Other group
Description:
Obese group with fat overload intake.
Treatment:
Dietary Supplement: High fat meal
Control Group
Other group
Description:
Control Group + fat overload intake
Treatment:
Dietary Supplement: High fat meal
Glucose Intolerance
Other group
Description:
glucose intolerance + fat overload intake
Treatment:
Dietary Supplement: High fat meal

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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