Trial · NCT02653092
Reprometabolic Syndrome Mediates Subfertility in Obesity
NCT02653092, Not applicable, Active not recruiting, University of Colorado, Denver; results first posted 2023-06-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Reprometabolic Syndrome Mediates Subfertility in Obesity. Trials, record NCT02653092. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02653092
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reprometabolic Syndrome Mediates Subfertility in Obesity
- NCT number
- NCT02653092
- Status
- Active not recruiting
- Phases
- Not applicable
- Enrollment
- 84 participants, actual
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Obesity, Infertility, Hypogonadotropic Hypogonadotropism, Hyperinsulinemia
- Interventions
- Insulin, Intralipid, Dextrose, Heparin, GnRH, Hyperinsulinemic Euglycemic Clamp
- First posted
- 2016-01-12
- Last updated
- 2026-03-02
- Results first posted
- 2023-06-01
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in LH Pulse Amplitude Before and After Acute or Chronic FFA Administration | First 4 hours of the frequent blood sampling study before and after FFA administration | LH-Luteinizing Hormone Pulse Amplitude before and after administration of FFAs. This is a measure of the post supplementation frequent blood sampling session and the baseline session. |
| Primary | Change in Steady State Amount of Glucose Metabolized at the Set Insulin Infusion Rate Under Euglycemic Conditions | 30 minutes | Primary outcome will be M, which represents the steady state amount of glucose metabolized at the set insulin infusion rate under euglycemic conditions, which is equal to the glucose infused when the participant is euglycemic during the second stage of the HEC49. The final 30 minutes of the clamp period will be considered steady state. Glucose concentrations will be determined with the glucose oxidase method (Beckman Glucose Analyzer 2; Beckman Instruments, Fullerton, CA), while ELISA methods will be used for insulin measurements (Alpco, Salem, NH). |
| Secondary | Change in GnRH Response Before and After Acute or Chronic FFA Administration | After the administration of GnRH at each FSS before and after acute and chronic FFA administration was assessed for up to 4 hours. | GnRH response will be compared between the non-intervention and intervention study as described above for gonadotropin pulsatility. The Investigator have used area under the curve methods to determine the LH response to exogenous GnRH and will utilize the same methodology as the investigator have done in the past. |
| Secondary | Change in Mean FSH Parameter Before and After Acute or Chronic FFA Administration | Before and after FFA adminstration | FSH parameters will be compared between the non-intervention and intervention studies for both aims as described above for gonadotropin pulsatility. The investigator will compare mean FSH, as pulsatility of FSH is less obvious than LH. |
| Secondary | Changes in Gonadotropin Pulse Frequency | 4 hours | The investigator will compare changes in gonadotropin pulse frequency (for LH, and if we can detect distinct FSH pulses, we will compare FSH as well), mean LH and FSH and kinetics of LH, and if possible, FSH, before and after the intervention, as previously reported |
| Secondary | Urinary Hormone Profiles Before, During and After High Fat Diet Administration. | Urinary assays will be measured for 4 menstrual cycles (approximately 4 months or 115 days) | Urinary hormone profiles will be assessed for the entire cycle before and two cycles after initiation of the HFD using previously described menstrual cycle parameters suitable for urinary hormone determinations. The LH peak will be determined for all cycles that demonstrate a Progesterone increment consistent with ovulation. Follicular and luteal phase lengths will be calculated, as will integrated follicular, luteal and whole cycle LH, FSH, E1c and Progesterone. The measurement is the change in value from baseline to 4 menstrual cycles (approximately 4 months) after baseline. |
| Secondary | Glucose Measurements Before and After FFA Administration. | 60 Minutes during HEC | Glucose will be measured by the CTRC laboratories before and after FFA administration.. |
| Secondary | Comparison of RBC Lipids Before and After the FFA Administration | 30 Minutes during the HEC | RBC lipids will also be compared, as the investigator predict that the HFD will result in increased omega-6 rich FFAs and less omega-3 FFAs |
| Secondary | DEXA Body Composition Comparison | 5 months-before and after the interventation. | DEXA body composition will be measured before and after the intervention. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in LH Pulse Amplitude Before and After Acute or Chronic FFA Administration | First 4 hours of the frequent blood sampling study before and after FFA administration | There were only 15 women who completed Aim 1 of the study. There were 19 women who completed aim 2 of the study and one had to be excluded due to not meeting the inclusion criteria once in the study. | IU/L | MEAN |
| PRIMARY | Change in Steady State Amount of Glucose Metabolized at the Set Insulin Infusion Rate Under Euglycemic Conditions | 30 minutes | Aim 1 included 15 participants who completed the studies. In Aim 2 one participant was excluded due to the fact once the analysis was completed she did not meet the inclusion/exclusion criteria and the total number of participants who completed the clamp was 15 per study design. | mg/dL | MEAN |
| SECONDARY | Change in GnRH Response Before and After Acute or Chronic FFA Administration | After the administration of GnRH at each FSS before and after acute and chronic FFA administration was assessed for up to 4 hours. | All participants completed both Aim 1 and Aim 2 in the study. | IU/L*min | MEAN |
| SECONDARY | Change in Mean FSH Parameter Before and After Acute or Chronic FFA Administration | Before and after FFA adminstration | normal weight women | IU/L*min | MEAN |
| SECONDARY | Changes in Gonadotropin Pulse Frequency | 4 hours | Normal Weight women | IU/L | MEAN |
| SECONDARY | Urinary Hormone Profiles Before, During and After High Fat Diet Administration. | Urinary assays will be measured for 4 menstrual cycles (approximately 4 months or 115 days) | Eighteen Normal weight women urinary hormones were measured during 4 menstrual cycles which was before, during and after the high fat diet administration. We looked at the change in peak LH before and after the high fat diet. | mIU/mg Creatinine | MEAN |
| SECONDARY | Glucose Measurements Before and After FFA Administration. | 60 Minutes during HEC | |||
| SECONDARY | Comparison of RBC Lipids Before and After the FFA Administration | 30 Minutes during the HEC | |||
| SECONDARY | DEXA Body Composition Comparison | 5 months-before and after the interventation. |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in LH Pulse Amplitude Before and After Acute or Chronic FFA Administration | Aim 1-Supplementation of FFAs in an Acute or Chronic Model. | 2.33 | Standard Error 1.21 | IU/L | |
| Change in LH Pulse Amplitude Before and After Acute or Chronic FFA Administration | Aim 2-Hyperinsulinemic Euglycemic Clamp. | 2.4 | Standard Error 1.1 | IU/L | |
| Change in Steady State Amount of Glucose Metabolized at the Set Insulin Infusion Rate Under Euglycemic Conditions | Aim 1-Acute and Chronic Administration of FFAs. | 1.98 | Standard Error 0.14 | mg/dL | |
| Change in Steady State Amount of Glucose Metabolized at the Set Insulin Infusion Rate Under Euglycemic Conditions | Aim 2-Hyperinsulinemic Euglycemic Clamp | 0.0485 | Standard Error 0.0641 | mg/dL | |
| Change in GnRH Response Before and After Acute or Chronic FFA Administration | Aim 1-Administration of FFA in an Acute Model | 567.63 | Standard Error 1.22 | IU/L*min | |
| Change in GnRH Response Before and After Acute or Chronic FFA Administration | Aim 2-Hyperinsulinemic Euglycemic Clamp After a Chronic Administration of a Diet | 355.12 | Standard Error 1.23 | IU/L*min | |
| Change in Mean FSH Parameter Before and After Acute or Chronic FFA Administration | Aim 1-Supplementation of FFAs in an Acute or Chronic Model. | 242.46 | Standard Error 1.23 | IU/L*min | |
| Change in Mean FSH Parameter Before and After Acute or Chronic FFA Administration | Aim 2-Hyperinsulinemic Euglycemic Clamp. | 158.99 | Standard Error 1.25 | IU/L*min | |
| Changes in Gonadotropin Pulse Frequency | Aim 1-Supplementation of FFAs in an Acute or Chronic Model. | 2.33 | Standard Error 1.21 | IU/L | |
| Changes in Gonadotropin Pulse Frequency | Aim 2-Hyperinsulinemic Euglycemic Clamp. | 1.49 | Standard Error 1.23 | IU/L |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aim 1-Acute Infusion of FFA and Chronic Model | 26 | |
| Overall Study | STARTED | Aim 2- Hyperinsulinemic Euglycemic Clamp | 58 | |
| Overall Study | COMPLETED | Aim 1-Acute Infusion of FFA and Chronic Model | 13 | |
| Overall Study | COMPLETED | Aim 2- Hyperinsulinemic Euglycemic Clamp | 18 | |
| Overall Study | NOT COMPLETED | Aim 1-Acute Infusion of FFA and Chronic Model | 13 | |
| Overall Study | NOT COMPLETED | Aim 2- Hyperinsulinemic Euglycemic Clamp | 40 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache and Nausea | Investigations | Aim 1 | 1 | 13 | 1 |
| other | Headache and Nausea | Investigations | Aim 2 | 18 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aim 1 | 0 | 13 |
| Total, all-cause mortality | Aim 2 | 0 | 18 |
| Total, other adverse events | Aim 1 | 1 | 13 |
| Total, other adverse events | Aim 2 | 0 | 18 |
| Total, serious adverse events | Aim 1 | 0 | 13 |
| Total, serious adverse events | Aim 2 | 0 | 18 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UL1TR001082 | Colorado Clinical and Translational Sciences Institute | SOKOL, RONALD J. | UNIVERSITY OF COLORADO DENVER | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2013 to 2017 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Aim 1 vs Aim 2: deaths from any cause | Trial comparisons |
| Aim 1 vs Aim 2: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02653092
GET https://conductscience.org/api/trials/v1/NCT02653092/registered