Trial · NCT00140231

Role of Leptin in the Neuroendocrine and Immune Response to Fasting

NCT00140231, Phase 1, Phase 2, Completed, Beth Israel Deaconess Medical Center; results first posted 2017-06-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Role of Leptin in the Neuroendocrine and Immune Response to Fasting. Trials, record NCT00140231. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00140231

On this page

Trial

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

Title: Role of Leptin in the Neuroendocrine and Immune Response to Fasting
NCT number: NCT00140231
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 13 participants, actual
Lead sponsor: Beth Israel Deaconess Medical Center
Conditions: Fasting
Interventions: r-metHuLeptin, placebo
First posted: 2005-09-01
Last updated: 2017-06-07
Results first posted: 2017-06-07
Limitations and caveats: Our study is confined to lean, healthy female subjects; therefore, our results should not be generalized to male, obese,or diabetic subjects

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Cortisol	four days
Primary	ACTH Mean Level	4 days	Response of ACTH to leptin administration in fed and fasting state from baseline was measured
Primary	Immune Function CD3 Count	4 days
Secondary	%Fat Mass	four days
Secondary	(RMR)	four days	Resting Metabolic rate using calorimetry
Secondary	Autonomic Function	four days	aldosterone level were measured on day 4 in response to leptin in fed and fasting states and compared with baseline level on day 1

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Cortisol	four days	ug/dl	MEAN
PRIMARY	ACTH Mean Level	4 days	pg/ml	MEAN
PRIMARY	Immune Function CD3 Count	4 days	cells/ul	MEAN
SECONDARY	%Fat Mass	four days	fat%	MEAN
SECONDARY	(RMR)	four days	kcal/d	MEAN
SECONDARY	Autonomic Function	four days	pg/ml	MEAN

Source ClinicalTrials.gov

Results by group16

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

Outcome	Group	Category	Value	Spread	Units
Cortisol	Metreleptin		17.5	Standard Deviation 0.9	ug/dl
Cortisol	Placebo		16.9	Standard Deviation 1.9	ug/dl
ACTH Mean Level	Metreleptin	baseline fed	10.48	Standard Error 1.28	pg/ml
ACTH Mean Level	Placebo	baseline fed	9.33	Standard Error 1.23	pg/ml
ACTH Mean Level	Metreleptin	fasting	9.89	Standard Error 2.01	pg/ml
ACTH Mean Level	Placebo	fasting	8.74	Standard Error 1.75	pg/ml
Immune Function CD3 Count	Metreleptin		302	Standard Error 185	cells/ul
Immune Function CD3 Count	Placebo		838	Standard Error 268	cells/ul
%Fat Mass	Metreleptin		29.1	Standard Deviation 2.2	fat%
%Fat Mass	Placebo		29.3	Standard Deviation 1.9	fat%

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow30

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

Period	Milestone	Group	Participants
Fed State 1 Day- day5	STARTED	Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo	7
Fed State 1 Day- day5	STARTED	Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Met	6
Fed State 1 Day- day5	COMPLETED	Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo	7
Fed State 1 Day- day5	COMPLETED	Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Met	6
Fed State 1 Day- day5	NOT COMPLETED	Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo	0
Fed State 1 Day- day5	NOT COMPLETED	Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Met	0
Washout 8weeks	STARTED	Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo	7
Washout 8weeks	STARTED	Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Met	6
Washout 8weeks	COMPLETED	Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo	7
Washout 8weeks	COMPLETED	Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Met	6

1 to 10 of 30Source ClinicalTrials.gov

See all 30 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	At risk
Total, all-cause mortality	Metreleptin	13
Total, all-cause mortality	Placebo	13
Total, other adverse events	Metreleptin	13
Total, other adverse events	Placebo	13
Total, serious adverse events	Metreleptin	13
Total, serious adverse events	Placebo	13

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
12727933	BACKGROUND	PubMed
21917874	DERIVED	PubMed
23193213	DERIVED	PubMed
25540981	DERIVED	PubMed
33051459	DERIVED	PubMed
35820631	DERIVED	PubMed
39097160	DERIVED	PubMed

Grants2

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	Source
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	NIH RePORTER
M01RR001032	General Clinical Research Center	SUKHATME, VIKAS P	BETH ISRAEL DEACONESS MEDICAL CENTER	NATIONAL CENTER FOR RESEARCH RESOURCES	1985 to 2008	NIH RePORTER

Trial comparisons2

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

Comparison	Source
Metreleptin vs Placebo: deaths from any cause	Trial comparisons
Metreleptin vs 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/NCT00140231

GET https://conductscience.org/api/trials/v1/NCT00140231/flow?page=2

API reference For AI assistants