Trial · NCT01419535

Mifepristone Effects on Glucose Intolerance in Obese/Overweight Adults

NCT01419535, Phase 1, Phase 2, Completed, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); results first posted 2021-04-14

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Mifepristone Effects on Glucose Intolerance in Obese/Overweight Adults. Trials, record NCT01419535. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01419535

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Mifepristone Effects on Glucose Intolerance in Obese/Overweight Adults
NCT number: NCT01419535
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 19 participants, actual
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions: Endocrine Disease, Diabetes
Interventions: Mifepristone, Placebo
First posted: 2011-08-18
Last updated: 2021-04-14
Results first posted: 2021-04-14

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Insulin Sensitivity Index	Nine days	insulin sensitivity index based on the effect of insulin on glucose during frequently sampled intravenous glucose tolerance test (FSIVGTT)
Secondary	Change in Fasting Plasma Glucose	Nine days	fasting plasma glucose after study agent compared to baseline
Secondary	Change in Fasting Insulin Levels	9 days	Fasting insulin after study agent administration compared to baseline
Secondary	Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	9 days	HOMA-IR is an index of insulin resistance, measured as glucose in mmol/L x insulin in mIU/mL)/22.5. HOMA-IR \> 2.5 indicates insulin resistance.
Secondary	Adipose-tissue Insulin Resistance Index (Adipo-IR)	9 days	The adipose tissue insulin resistance index (Adipo-IR), a surrogate measure for fasting adipose-tissue insulin resistance, was calculated as the product of fasting insulin and fasting free fatty acids (FFA)
Secondary	Adipose-tissue Insulin Sensitivity Index (Adipo-SI)	9 days	The Adipo-SI was calculated as ratio of the slope of the linear decrease in natural log transformed FFA \[Ln (FFA) slope\] during the first 90 minutes of the FSIVGTT and the area under the curve (AUC) of insulin during that 90-minute period (AUC Insulin 0-90 min).

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Insulin Sensitivity Index	Nine days	2 subjects in each group missing data due to iv line problems	min-1·μU·ml-1	MEAN
SECONDARY	Change in Fasting Plasma Glucose	Nine days		mg/dL	MEAN
SECONDARY	Change in Fasting Insulin Levels	9 days		pmol/L	MEAN
SECONDARY	Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	9 days		units on a scale	MEAN
SECONDARY	Adipose-tissue Insulin Resistance Index (Adipo-IR)	9 days		mmol/l·μU/l	MEAN
SECONDARY	Adipose-tissue Insulin Sensitivity Index (Adipo-SI)	9 days		ln(mmol /uU/mLmin)10^8	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Insulin Sensitivity Index	Post-mifepristone	1.49	Standard Deviation 1.17	min-1·μU·ml-1
Change in Insulin Sensitivity Index	Post-placebo	1.41	Standard Deviation 0.87	min-1·μU·ml-1
Change in Fasting Plasma Glucose	Post-mifepristone	100.4	Standard Error 5.3	mg/dL
Change in Fasting Plasma Glucose	Post-placebo	107.8	Standard Error 15.7	mg/dL
Change in Fasting Insulin Levels	Post-mifepristone	95.6	Standard Deviation 76.1	pmol/L
Change in Fasting Insulin Levels	Post-placebo	142.8	Standard Deviation 102.2	pmol/L
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	Post-mifepristone	3.58	Standard Deviation 3.27	units on a scale
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	Post-placebo	5.78	Standard Deviation 4.92	units on a scale
Adipose-tissue Insulin Resistance Index (Adipo-IR)	Post-mifepristone	49.9	Standard Deviation 45.9	mmol/l·μU/l
Adipose-tissue Insulin Resistance Index (Adipo-IR)	Post-placebo	65.5	Standard Deviation 43.8	mmol/l·μU/l

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Mifepristone, Then Placebo	9
Overall Study	STARTED	Placebo, Then Mifepristone	10
Overall Study	COMPLETED	Mifepristone, Then Placebo	8
Overall Study	COMPLETED	Placebo, Then Mifepristone	8
Overall Study	NOT COMPLETED	Mifepristone, Then Placebo	1
Overall Study	NOT COMPLETED	Placebo, Then Mifepristone	2

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	abnormal blood chemistry	Hepatobiliary disorders	Post-mifepristone	0	16	0
other	abnormal blood chemistry	Hepatobiliary disorders	Post-placebo	2	16	2

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Post-mifepristone	0	16
Total, all-cause mortality	Post-placebo	0	16
Total, other adverse events	Post-mifepristone	0	16
Total, other adverse events	Post-placebo	2	16
Total, serious adverse events	Post-mifepristone	0	16
Total, serious adverse events	Post-placebo	0	16

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
15850845	BACKGROUND	PubMed
17148736	BACKGROUND	PubMed
19470627	BACKGROUND	PubMed
33507248	DERIVED	PubMed

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
ZIADK075121	The Physiology Of Hypercortisolism	NIEMAN, LYNNETTE	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2016 to 2024

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Post-mifepristone vs Post-placebo: deaths from any cause	Trial comparisons
Post-mifepristone vs Post-placebo: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01419535

GET https://conductscience.org/api/trials/v1/NCT01419535/registered

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