Study About High Fat Meal and Postprandial Lipemia
Evaluating the Effect of Lipid Overload in Endothelial Function and Microvascular Reactivity in Young Obese Women
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Sep 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 12, 2012
CompletedFirst Posted
Study publicly available on registry
September 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedNovember 5, 2014
November 1, 2014
3 months
September 12, 2012
November 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Microvascular function
up to 180 minutes after high fat meal
Secondary Outcomes (1)
incretins hormones
basal, 30, 60, 120,180 minutes after high fat meal
Study Arms (3)
Obese Group
OTHERObese group with fat overload intake.
Control Group
OTHERControl Group + fat overload intake
Glucose Intolerance
OTHERglucose intolerance + fat overload intake
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rio de Janeiro State University
Rio de Janeiro, Rio de Janeiro, 20550900, Brazil
Related Publications (1)
de Souza MDGC, Maranhao PA, Panazzolo DG, Nogueira Neto JF, Bouskela E, Kraemer-Aguiar LG. Effects of a high-fat meal on inflammatory and endothelial injury biomarkers in accordance with adiposity status: a cross-sectional study. Nutr J. 2022 Oct 19;21(1):65. doi: 10.1186/s12937-022-00819-4.
PMID: 36258233DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nutricionist
Study Record Dates
First Submitted
September 12, 2012
First Posted
September 25, 2012
Study Start
September 1, 2012
Primary Completion
December 1, 2012
Study Completion
July 1, 2014
Last Updated
November 5, 2014
Record last verified: 2014-11