Terminé

MAROMediators of Abnormal Reproductive Function in Obesity

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Ce qui est testé

Microdialysis

+ Vascepa - Fish Oil

+ Aspirin

AutreComplément alimentaireMédicament
Qui peut participer

Maladies génito-urinaires+12

+ Maladies Génitales

+ Poids Corporel

De 18 à 60 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Recherche fondamentale

Phase 1 précoce
Interventionnel
Date de début : mars 2013
Voir le détail du protocole

Résumé

Sponsor principalUniversity of Colorado, Denver
Dernière mise à jour : 17 mars 2015
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 mars 2013

Date à laquelle le premier participant a commencé l'étude.

Specific Aim 1: To determine whether aromatase activity is measurable in adipose tissue using the 'compound' (see appendix) as a precursor and whether aromatase is decreased in the adipose tissue of obese women, and whether this varies by regional fat location. The investigators will accomplish this by examining precursor/product ratios of hormones infused through microdialysis using the 'compound' as a substrate. Hypothesis for specific aim 1: Aromatase activity will be measurable in adipose tissue using testosterone as a precursor. Estradiol, but not estrone production from androgen precursors will be decreased in obese women relative to those of normal weight. Specific Aim 2: To determine whether nonspecific, systemic suppression of inflammation will lead to improved reproductive hormonal profiles of luteinizing hormone (LH), follicle stimulating hormone(FSH), Estrone conjugates (E1c) and pregnandiol glucuronide (Pdg) in obese women who undergo two menstrual cycles of study: one off treatment and one on treatment. This aim shall be accomplished by performing daily urinary hormone monitoring of two menstrual cycles, one prior to and one during treatment with low-dose aspirin and polyunsaturated fatty acids (PUFAs). Hypothesis for specific aim 2: A nonspecific, systemic inflammatory suppression therapy will result in improved urinary profiles of LH, FSH, E1c and Pdg. Specific Aim 3: To determine whether 4 weeks of reduction of circulating insulin will result in improved reproductive hormonal profiles of LH, FSH, Estrone conjugates (E1c) and pregnandiol glucuronide (Pdg) in obese women who undergo two menstrual cycles of study: one off treatment and one on treatment. This aim shall be accomplished by performing daily urinary hormone monitoring of two menstrual cycles, one prior to and one during treatment with pioglitazone. Hypothesis for specific aim 3: Chronic lowering of insulin with pioglitazone treatment of obese women will result in improved urinary profiles of LH, FSH, E1c and Pdg.

NCT01817400
Sponsor principalUniversity of Colorado, Denver
Dernière mise à jour : 17 mars 2015
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

10 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Recherche fondamentale

Cette étude cherche à mieux comprendre les mécanismes biologiques à l'origine d'une maladie ou d'un problème de santé, sans viser directement un traitement.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Femme

Le sexe biologique des participants éligibles à s'inscrire.

De 18 à 60 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies génito-urinairesMaladies GénitalesPoids CorporelMaladies urogénitales féminines et complications de la grossesseMaladies génitales fémininesInfertilitéTroubles de la NutritionMaladies nutritionnelles et métaboliquesSignes et symptômesConditions pathologiques, signes et symptômesSuralimentationSurpoidsMaladies urogénitales fémininesInfertilité féminineObésité

Critères

Inclusion Criteria: Women aged 18-39* who meet the following criteria will be enrolled: *Women age 40-60 can be enrolled in Group A BMI at least 30 kg/m2 (Groups B and C only) No history of chronic disease affecting hormone production, metabolism or clearance No use of medications known to alter or interact with reproductive hormones or insulin metabolism (e.g. thiazolidinediones, metformin) No use of reproductive hormones within 3 months of enrollment No medical conditions that are known to affect urinary hormone excretion or that may interfere with urinary hormone measurement (Groups B and C only) No history of or active bladder cancer (Group C only, since pioglitazone is contraindicated in individuals with bladder cancer) Normal prolactin and thyroid stimulating hormone levels at screening History of regular menstrual cycles every 25-40 days Use of a reliable method of contraception (female or male partner sterilization; intrauterine device (IUD); abstinence; diaphragm) Hemoglobin A1c <6% Exclusion Criteria: Women aged 18-39* who meet the following criteria will be enrolled: *Women age 40-60 can be enrolled in Group A BMI at least 30 kg/m2 (Groups B and C only) No history of chronic disease affecting hormone production, metabolism or clearance No use of medications known to alter or interact with reproductive hormones or insulin metabolism (e.g. thiazolidinediones, metformin) No use of reproductive hormones within 3 months of enrollment No medical conditions that are known to affect urinary hormone excretion or that may interfere with urinary hormone measurement (Groups B and C only) No history of or active bladder cancer (Group C only, since pioglitazone is contraindicated in individuals with bladder cancer) Normal prolactin and thyroid stimulating hormone levels at screening History of regular menstrual cycles every 25-40 days Use of a reliable method of contraception (female or male partner sterilization; IUD; abstinence; diaphragm) Hemoglobin A1c <6%

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

3 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
Microdialysis probes will be inserted into the abdominal and femoral subcutaneous adipose tissue. Two "control" probes at each site will be perfused at 2.0 µL/min with Ringer's solution to measure basal interstitial testosterone and estradiol levels. One "experimental" probe at each site will be perfused with the 'compound' 20ug/dl at 2.0 µL/min to assess the interstitial conversion of androstenedione to estrone and estradiol. The 'compound' will be infused. Either one or the other hormone (androstenedione OR testosterone) will be used per experiment. The second "control" probe will be positioned at each site to ensure acquisition of data in the event that one of the other probes becomes dysfunctional. We will then collect microdialysis samples every 60 min over the next 120 min.

Groupe II

Expérimental
We will perform a control cycle of daily, first-morning voided urine, as previously reported by our group to assess the hormonal features of the menstrual cycle of each of the five participants in this arm. Upon completion of the control cycle, the participant will initiate therapy with aspirin 81mg per day, plus Vascepa - Fish Oil 30mg daily. Participants will collect urine for a second menstrual cycle while on treatment, using methods that we have previously employed. At the completion of the second cycle of urine collection, the medications will be stopped and the study will be completed.

Groupe III

Expérimental
We will perform a control cycle of daily, first morning voided urine as previously reported by our group, to assess the hormonal features of the menstrual cycle of each of the five participants. Upon completion of the control cycle, the participant will initiate therapy with pioglitazone, 45 mg daily, a dose that has previously been shown to result in a 30% reduction in fasting insulin. She will take the pioglitazone without any monitoring for a second menstrual cycle and then collect urinary hormones for the third menstrual cycle, continuing the pioglitazone until the third menstrual cycle is completed.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

University of Colorado Denver Anschutz Medical Campus

Aurora, United StatesOuvrir University of Colorado Denver Anschutz Medical Campus dans Google Maps
Terminé1 Centres d'Étude