Trial · NCT00140244

Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome

NCT00140244, Phase 2, Completed, Beth Israel Deaconess Medical Center; results first posted 2017-04-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome. Trials, record NCT00140244. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00140244

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Trial

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

Title: Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome
NCT number: NCT00140244
Status: Completed
Phases: Phase 2
Enrollment: 7 participants, actual
Lead sponsor: Beth Israel Deaconess Medical Center
Conditions: HAART-induced Lipodystrophy and Metabolic Syndrome
Interventions: r-metHuLeptin, Placebo
First posted: 2005-09-01
Last updated: 2017-05-11
Results first posted: 2017-04-06

Source ClinicalTrials.gov

Registered outcomes13

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

List	Outcome	Time frame	Description
Primary	Serum Lipid Levels	At the end of each two month intervention
Secondary	Insulin Resistance (as Assessed by HOMA-IR)	At the end of each two month intervention
Secondary	Glycemia (as Assessed by Fasting Glucose)	At the end of each two month intervention
Secondary	Low Density Lipoprotein (LDL) Cholesterol Levels	At the end of each two month intervention
Secondary	Free Fatty Acid (FFA) Levels	At the end of each two month intervention
Secondary	Blood Pressure	At the end of each two month intervention	percent change in mean blood pressure
Secondary	Fibrinogen	At the end of each two month intervention	Fibrinogen
Secondary	Insulin Levels	At the end of each two month intervention
Secondary	Lean Body Mass	At the end of each two month intervention	lean body mass
Secondary	Viral Load	At the end of each two month intervention

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Serum Lipid Levels	At the end of each two month intervention	mg/dl	MEAN
SECONDARY	Insulin Resistance (as Assessed by HOMA-IR)	At the end of each two month intervention	units on a scale	MEAN
SECONDARY	Glycemia (as Assessed by Fasting Glucose)	At the end of each two month intervention	mg/dl	MEAN
SECONDARY	Low Density Lipoprotein (LDL) Cholesterol Levels	At the end of each two month intervention	mg/dl	MEAN
SECONDARY	Free Fatty Acid (FFA) Levels	At the end of each two month intervention	mEq/liter	MEAN
SECONDARY	Blood Pressure	At the end of each two month intervention	percentage change of mean blood pressure	LEAST_SQUARES_MEAN
SECONDARY	Fibrinogen	At the end of each two month intervention	mg/dL	MEAN
SECONDARY	Insulin Levels	At the end of each two month intervention	mcIU/ml	MEAN
SECONDARY	Lean Body Mass	At the end of each two month intervention	kg	MEAN
SECONDARY	Viral Load	At the end of each two month intervention	copies/ml	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group34

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

Outcome	Group	Category	Value	Spread	Units
Serum Lipid Levels	r-MetHuLeptin	total cholesterol	228.8	Standard Error 13.3	mg/dl
Serum Lipid Levels	Placebo	total cholesterol	219.7	Standard Error 13.1	mg/dl
Serum Lipid Levels	r-MetHuLeptin	low density lipoprotein cholesterol	113.0	Standard Error 12.7	mg/dl
Serum Lipid Levels	Placebo	low density lipoprotein cholesterol	105.7	Standard Error 3.33	mg/dl
Serum Lipid Levels	r-MetHuLeptin	triglycerides	409.0	Standard Error 88.8	mg/dl
Serum Lipid Levels	Placebo	triglycerides	520.5	Standard Error 91.1	mg/dl
Serum Lipid Levels	r-MetHuLeptin	high density lipoprotein cholesterols	35	Standard Error 2.23	mg/dl
Serum Lipid Levels	Placebo	high density lipoprotein cholesterols	29.96	Standard Error 2.25	mg/dl
Serum Lipid Levels	r-MetHuLeptin	Free fatty acids	0.45	Standard Error 0.07	mg/dl
Serum Lipid Levels	Placebo	Free fatty acids	0.61	Standard Error 0.09	mg/dl

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Intervention 1	STARTED	r-MetHuLeptin First, Then Placebo	3
Intervention 1	STARTED	Placebo First, Then r-metHuLeptin	4
Intervention 1	COMPLETED	r-MetHuLeptin First, Then Placebo	3
Intervention 1	COMPLETED	Placebo First, Then r-metHuLeptin	4
Intervention 1	NOT COMPLETED	r-MetHuLeptin First, Then Placebo	0
Intervention 1	NOT COMPLETED	Placebo First, Then r-metHuLeptin	0
Washout	STARTED	r-MetHuLeptin First, Then Placebo	3
Washout	STARTED	Placebo First, Then r-metHuLeptin	4
Washout	COMPLETED	r-MetHuLeptin First, Then Placebo	3
Washout	COMPLETED	Placebo First, Then r-metHuLeptin	4

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

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 totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	r-MetHuLeptin
Total, all-cause mortality	Placebo
Total, other adverse events	r-MetHuLeptin	0	5
Total, other adverse events	Placebo	0	7
Total, serious adverse events	r-MetHuLeptin	0	5
Total, serious adverse events	Placebo	0	7

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21081243	DERIVED	PubMed
35820631	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
R01DK058785	Role of leptin in the neuroendocrine response to fasting	MANTZOROS, CHRISTOS S	BETH ISRAEL DEACONESS MEDICAL CENTER	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2001 to 2011

Source NIH RePORTER

Trial comparisons1

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

Comparison
r-MetHuLeptin vs Placebo: 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/NCT00140244

GET https://conductscience.org/api/trials/v1/NCT00140244/results?page=2

API reference For AI assistants