Trial · NCT05713799
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
NCT05713799, Phase 2, Not yet recruiting, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity. Trials, record NCT05713799. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05713799
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
- NCT number
- NCT05713799
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Conditions
- Insulin Resistance, Obesity
- Interventions
- Alpha-lipoic acid, Mirabegron, Placebo
- First posted
- 2023-02-06
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in the Insulin sensitivity index (SI) obtained from FSIGT, in (mU/L)^-1 * min^-1 | Insulin sensitivity index measured before and after each intervention in sequence | Change in the Insulin sensitivity index before and after 4 weeks of MG and ALA minus change in the insulin sensitivity index before and after 4 weeks of MG and placebo. This measures a change in insulin sensitivity index following ALA while controlling for changes in insulin sensitivity index due to placebo.Delta SI = (SI after ALA - SI before ALA)- (SI after placebo - SI before placebo) |
| Secondary | Maximum observed plasma concentration of ALA (Cmax) | 0-6 hours after dose of MG+ALA | Maximum observed plasma concentration of ALA in ug/mL, measured in serial blood sampling conducted in first 6 hours following MG+ALA dose at study visit |
| Secondary | Time to maximum observed plasma concentration of ALA (Tmax) | 0-6 hours after dose of MG+ALA | Tmax of ALA in minutes, measured in serial blood sampling conducted in first 6 hours following MG+ALA dose at study visit |
| Secondary | Area under the concentration-time curve for ALA | 0-6 hours after dose of MG+ALA | AUC calculated by measuring ALA concentrations in serial blood samples taken in first 6 hours following MG+ALA dose at study visit |
| Secondary | Changes in adipose tissue local inflammation in adipose tissue biopsy samples | Measured before and after each intervention in sequence | Calculated as number of macrophages per high-power fieldChange in inflammation = (macrophages after ALA - macrophages before ALA) - (macrophages after placebo - macrophages before placebo) |
| Secondary | Changes in serum cytokines | Measured before and after each intervention in sequence | Measured in ug/mL of serumChange in cytokines = (cytokine concentration after ALA - cytokine concentration before ALA) - (cytokine concentration after placebo - cytokine concentration before placebo) |
| Secondary | Changes in plasma lipids | Measured before and after each intervention in sequence | Measured in uMol of lipids in plasma samplesChange in lipids = (lipid concentration after ALA - lipid concentration before ALA) - (lipid concentration after placebo - lipid concentration before placebo) |
| Secondary | Changes in the rate of steady-state whole-body lipolysis | Measured before and after each intervention in sequence | Measured as the rate of isotope appearance (Ra) of \[2H5\] glycerol in plasma, with units of mg/kg/minChange in Ra = (Ra after ALA - Ra before ALA) - (Ra after placebo - Ra before placebo) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT05713799
GET https://conductscience.org/api/trials/v1/NCT05713799/registered