Leptin Signaling in Lean and Obese Humans | NCT01297426

Studies
Leptin Signaling in Lean and Obese Humans

NCT01297426

Sponsor

VA Office of Research and Development

Status

Withdrawn

Last Update Posted

Dec 24, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Obesity

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

funding expired

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Feb 14, 2011

First Submission Date that Met QC Criteria

Feb 15, 2011

First Posted Date

Feb 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2015

Last Update Posted Date

Dec 24, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Obesity does not respond to high circulating levels of the hormone leptin. This study is aiming at finding out why this happens and open new avenues for treatment of obesity.

Detailed Description

Ex vivo and in vitro identification and study of leptin signaling pathways in commercially available cell lines serum/ plasma samples and discarded tissues from humans.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
Group 1		Lean and obese, diabetic and non diabetics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Westerns / activation of signaling pathways (uo to two hours after treatment)		04/01/2016

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

men and women
ages 18 to 65
BMI ranges between 20 and 45 kg/m2

Exclusion Criteria:

subjects requiring special diets
history of illness other than obesity of diabetes
taking medications known to influence glucose metabolism
subjects with history of anaphylactic reaction or hypersensitivity to e. coli derived proteins or anesthetic agents
women who are breastfeeding, pregnant or wanting to become pregnant
subjects with bleeding dyscrasia or poor wound healing

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

diabetic or nondiabetic lean and obese subjects

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christos Mantzoros, MD DSc	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA		Boston	Massachusetts	02130	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided