EQW, DAPA, EQW/DAPA, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS)
Trial · NCT02635386
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Oral Disposition (Insulin Sensitivity-insulin Secretion) Index | 24 weeks of treatment | An estimation of β-cell compensatory function, the insulin secretion-sensitivity index (IS-SI) will be derived by applying the concept of the oral disposition index to measurements obtained during the 2-h OGTT and calculated as the index of insulin secretion factored by insulin sensitivity (ΔINS/ΔPG 30 x Matsuda SIOGTT) from the OGTT. A higher score shows improved pancreatic insulin responsiveness relative to resistance. |
| Secondary | Absolute Body Weight | 24 weeks of treatment | Treatment effect on body weight at 24 weeks of treatment |
| Secondary | Body Mass Index (BMI) | 24 weeks of treatment | Treatment efficacy in reducing body mass at 24 weeks of treatment |
| Secondary | Change in Percent Body Weight | Change from baseline (time 0) to study end (24 weeks) | Treatment effect on change in percent body weight from baseline |
| Secondary | Central Adiposity (Waist Circumference) | 24 weeks of treatment | Treatment effect on loss of central adiposity after 24 weeks |
| Secondary | Waist-to-Hip Ratio (WHR) | 24 weeks of treatment | Treatment impact on central adiposity after 24 weeks |
| Secondary | Waist-to-Height Ratio (WHtR) | 24 weeks of treatment | Treatment impact on WHtR which is a measure of central adiposity |
| Secondary | Total Fat Mass (kg) Evaluated by DEXA | 24 weeks of treatment | Treatment impact on total fat mass by DEXA |
| Secondary | Total Body Fat (%) by DEXA | 24 weeks of treatment | Treatment impact on percent total body fat by DEXA |
| Secondary | Android-Gynoid Ratio (AGR) as Determined by DEXA | 24 weeks of treatment | treatment impact on measure of central adiposity as determined by android/gynoid ratio |
| Secondary | Trunk/Leg Fat Ratio by DEXA | 24 weeks of treatment | Treatment impact on trunk/limb ratio (measure of central adiposity) by DEXA |
| Secondary | Fasting Blood Glucose | 24 weeks of treatment | Treatment impact on fasting concentration of glucose in the blood |
| Secondary | OGTT Mean Blood Glucose (MBG) | 24 weeks of treatment | Treatment effect on MBG measured during the oral glucose tolerance test |
| Secondary | Fasting Insulin Sensitivity (HOMA-IR) | 24 weeks of treatment | Treatment effect on the ratio HOMA-IR which is insulin resistance measure derived from fasting blood glucose and insulin and is calculated by insulin (mU/ml)\*glucose (mmol/L)/22,5. The higher thenumber the more insulin resistant. |
| Secondary | Matsuda Sensitivity Index Derived From the OGTT(SI OGTT) | 24 weeks of treatment | The SI IOGTT is a measure of peripheral insulin sensitivity derived from the values of Insulin (microunits per milliliter) and Glucose (milligrams per deciliter) obtained from the OGTT and the corresponding fasting values. SI (OGTT) = 10,000/ \[(G fasting x I fasting) x (G OGTTmean x I OGTTmean)\], where fasting glucose and insulin data are taken from time 0 of the OGTT and mean data represent the average glucose and insulin values obtained during the entire OGTT. The square root is used to correct for nonlinear distribution of insulin, and 10,000 is a scaling factor in the equation. The higher value, the more sensitive to insulin. |
| Secondary | Corrected First Phase Insulin Secretion (IGI/HOMA-IR) | 24 weeks of treatment | Treatment effect on insulin secretion from 0 to 30 minutes after glucose load corrected for by fasting insulin sensitivity. A higher score shows improved first phase insulin secretion in response to glucose |
| Secondary | Total Cholesterol Levels | 24 weeks of treatment | Treatment effect on blood concentrations of total cholesterol |
| Secondary | Triglyceride (TRG) Levels | 24 weeks of treatment | Treatment effect on blood concentrations of triglycerides |
| Secondary | Total Testosterone Concentrations | 24 weeks of treatment | Treatment effect on blood concentrations of total testosterone |
| Secondary | Dehydroepiandrosterone Sulfate (DHEA-S) Levels | 24 weeks of treatment | Treatment effect on blood concentrations of DHEA-S |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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