Mediators of Abnormal Reproductive Function in Obesity (MARO)

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Infertility, FemaleObesity
Interventions
OTHER

Microdialysis

"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."

DIETARY_SUPPLEMENT

Vascepa - Fish Oil

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 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.

DRUG

Aspirin

DRUG

Pioglitazone

e 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.

Trial Locations (1)

80045

University of Colorado Denver Anschutz Medical Campus, Aurora

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

University of Colorado, Denver

OTHER

NCT01817400 - Mediators of Abnormal Reproductive Function in Obesity (MARO) | Biotech Hunter | Biotech Hunter