Trial · NCT00005669

Metformin to Treat Obesity in Children With Insulin Resistance

NCT00005669, Phase 2, Completed, Jack Yanovski, M.D.; results first posted 2011-04-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Metformin to Treat Obesity in Children With Insulin Resistance. Trials, record NCT00005669. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00005669

On this page

Trial

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

Title: Metformin to Treat Obesity in Children With Insulin Resistance
NCT number: NCT00005669
Status: Completed
Phases: Phase 2
Enrollment: 100 participants, actual
Lead sponsor: Jack Yanovski, M.D.
Conditions: Hyperinsulinemia, Obesity
Interventions: Metformin HCL, Placebo
First posted: 2000-05-22
Last updated: 2015-05-08
Results first posted: 2011-04-07

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Changes in Body Weight as Determined by Body Mass Index-standard Deviation Score (BMI-SDS).	6 months	Change in Body Mass Index standard deviation score (BMI-SDS) determined using tables created by the CDC in 2000. BMI-SDS is a unitless transformation of the body mass index (measured in kg divided by the squared height in meters) using the L M S method. Possible values range from -3 to +3. See http://www.cdc.gov/growthcharts/percentile\_data\_files.htm for details.
Secondary	Change in Body Weight as Determined by BMI	6 months	Change in body weight as determined by body mass index (kg/m2)
Secondary	Change in Body Weight	6 months	Change in body weight (kg)
Secondary	Change in Body Fat by DEXA	6 months	Change in body fat mass by Dual Energy X-Ray Absorptiometry (kg)
Secondary	Change in Body Fat by Bod Pod	6 months	Change in body fat mass measured by air displacement plethysmography (kg)

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Changes in Body Weight as Determined by Body Mass Index-standard Deviation Score (BMI-SDS).	6 months		Units on a scale	MEAN
SECONDARY	Change in Body Weight as Determined by BMI	6 months		kg/m2	MEAN
SECONDARY	Change in Body Weight	6 months		kg	MEAN
SECONDARY	Change in Body Fat by DEXA	6 months	ITT, multiple imputation model for missing data under a missing-at-random assumption	kg	MEAN
SECONDARY	Change in Body Fat by Bod Pod	6 months		kg	MEAN

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Spread	Units
Changes in Body Weight as Determined by Body Mass Index-standard Deviation Score (BMI-SDS).	Metformin Plus Weight Reduction Counseling	-0.11	95% Confidence Interval -0.16 to -0.05	Units on a scale
Changes in Body Weight as Determined by Body Mass Index-standard Deviation Score (BMI-SDS).	Placebo Plus Weight Reduction Counseling	-0.07	95% Confidence Interval -0.12 to -0.01	Units on a scale
Change in Body Weight as Determined by BMI	Metformin Plus Weight Reduction Counseling	-0.78	95% Confidence Interval -1.54 to -0.01	kg/m2
Change in Body Weight as Determined by BMI	Placebo Plus Weight Reduction Counseling	0.32	95% Confidence Interval -0.54 to 1.18	kg/m2
Change in Body Weight	Metformin Plus Weight Reduction Counseling	1.47	95% Confidence Interval -0.31 to 3.24	kg
Change in Body Weight	Placebo Plus Weight Reduction Counseling	4.85	95% Confidence Interval 2.84 to 6.85	kg
Change in Body Fat by DEXA	Metformin Plus Weight Reduction Counseling	0.48	95% Confidence Interval -0.80 to 1.76	kg
Change in Body Fat by DEXA	Placebo Plus Weight Reduction Counseling	1.88	95% Confidence Interval 0.44 to 3.31	kg
Change in Body Fat by Bod Pod	Metformin Plus Weight Reduction Counseling	-1.51	95% Confidence Interval -4.56 to 1.54	kg
Change in Body Fat by Bod Pod	Placebo Plus Weight Reduction Counseling	1.81	95% Confidence Interval -1.64 to 5.25	kg

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Metformin Plus Weight Reduction Counseling	53
Overall Study	STARTED	Placebo Plus Weight Reduction Counseling	47
Overall Study	COMPLETED	Metformin Plus Weight Reduction Counseling	45
Overall Study	COMPLETED	Placebo Plus Weight Reduction Counseling	40
Overall Study	NOT COMPLETED	Metformin Plus Weight Reduction Counseling	8
Overall Study	NOT COMPLETED	Placebo Plus Weight Reduction Counseling	7

Source ClinicalTrials.gov

Adverse events14

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	Nausea	Gastrointestinal disorders	Metformin Plus Weight Reduction Counseling	28	53	55
other	Nausea	Gastrointestinal disorders	Placebo Plus Weight Reduction Counseling	17	47	18
other	Liquid Stools	Gastrointestinal disorders	Metformin Plus Weight Reduction Counseling	22	53	34
other	Liquid Stools	Gastrointestinal disorders	Placebo Plus Weight Reduction Counseling	8	47	8
other	Vomiting	Gastrointestinal disorders	Metformin Plus Weight Reduction Counseling	22	53	36
other	Vomiting	Gastrointestinal disorders	Placebo Plus Weight Reduction Counseling	10	47	10
other	Bloating	Gastrointestinal disorders	Metformin Plus Weight Reduction Counseling	13	53	20
other	Bloating	Gastrointestinal disorders	Placebo Plus Weight Reduction Counseling	6	47	7
other	Increased Bowel Movements	Gastrointestinal disorders	Metformin Plus Weight Reduction Counseling	22	53	25
other	Increased Bowel Movements	Gastrointestinal disorders	Placebo Plus Weight Reduction Counseling	11	47	13

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Metformin Plus Weight Reduction Counseling
Total, all-cause mortality	Placebo Plus Weight Reduction Counseling
Total, other adverse events	Metformin Plus Weight Reduction Counseling	48	53
Total, other adverse events	Placebo Plus Weight Reduction Counseling	46	47
Total, serious adverse events	Metformin Plus Weight Reduction Counseling	0	53
Total, serious adverse events	Placebo Plus Weight Reduction Counseling	0	47

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
8053753	BACKGROUND	PubMed
9481594	BACKGROUND	PubMed
20124139	BACKGROUND	PubMed
21228310	DERIVED	PubMed
25483291	DERIVED	PubMed
29718281	DERIVED	PubMed
38271099	DERIVED	PubMed

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 comparisons1

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

Comparison
Metformin Plus Weight Reduction Counseling vs Placebo Plus Weight Reduction Counseling: serious adverse events

Source 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/NCT00005669

GET https://conductscience.org/api/trials/v1/NCT00005669/registered

API reference For AI assistants