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Report for Clinical Trial NCT02463383

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Alcohol-related Breast Cancer in Postmenopausal Women - Effect of PPARG2pro12ala Polymorphism on Female Sex-hormone Levels and Interaction With Alcohol Consumption and NSAID Usage

Postmenopausal women, stratified by a peroxisome proliferator-activated receptor gamma-2 (PPARG) polymorphism, were given the following treatments in a random order with a 5w wash-out period: a 400mg ibuprofen tablet or a placebo tablet; both treatments were followed after 30min by a single acute dose of 0.4g alcohol per kg bw. Serum estrogen levels were measured before and at three timepoints after alcohol intake. It is hypothesized that the acute decrease in estrogen sulphate and other markers of estrogens after alcohol intake is modulated by ibuprofen and by PPARG genotype.

NCT02463383 Breast Cancer
MeSH:Breast Neoplasms
HPO:Breast carcinoma Neoplasm of the breast

2 Interventions

Name: Ibuprofen Tab 400 MG

Description: 400mg ibuprofen is provided and an alcohol challenge (0.4g/kg bw) is given 30min later
Type: Drug
Group Labels: 2

Sequence 1 Sequence 2

Name: Placebo tab

Description: A placebo tablet is provided and an alcohol challenge (0.4g/kg bw) is given 30min later
Type: Drug
Group Labels: 2

Sequence 1 Sequence 2


Primary Outcomes

Description: Plasma estrone sulfate concentration after acute ethanol intake by Ibuprofen intake and/or PPARG genotype

Measure: Serum estrone sulphate (pmol/l)

Time: from 40 min before to 90 min after alcohol consumption

Secondary Outcomes

Description: Plasma estrone decrease after acute ethanol intake by ibuprofen intake and/or PPARG genotype

Measure: Serum estrone (pmol/l)

Time: from 40 min before to 90 min after alcohol consumption

Description: Plasma SHBG concentration after acute ethanol ingestion by ibuprofen intake and/or PPARG genotype

Measure: Serum SHBG (nmol/l)

Time: from 40 min before to 90 min after alcohol consumption

Description: Plasma ethanol concentration after acute ethanol ingestion

Measure: Serum ethanol (g/l)

Time: from 40 min before to 90 min after alcohol consumption

Description: The plasma metabolome profile by time after alcohol intake

Measure: Serum metabolomics (relative metabolite intensity)

Time: from 40 min before to 24h after alcohol intake

Description: The urine metabolome profile by time after alcohol intake

Measure: Urine metabolomics (relative metabolite intensity)

Time: from 40 min before to 24h after alcohol intake

Purpose: Basic Science

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 P12A

cholesterol lowering medicine); 7. being allergic to alcohol and/or Ibuprofen 8. smoking Breast Cancer Breast Neoplasms In a pilot human intervention trial we aimed to determine the effect of the PPARG Pro12Ala polymorphism and the PPARĪ³ stimulator, Ibuprofen, on sex-hormone levels following alcohol intake in postmenopausal women. --- Pro12Ala ---

Seven women with PPARG Pro12Ala and 18 PPARG wildtype women were included.The study was performed as a randomised, double-blinded, placebo controlled 2x24 h crossover study. --- Pro12Ala ---



HPO Nodes


HPO: