NCT01297426

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

December 24, 2015

Status Verified

December 1, 2015

Enrollment Period

4.2 years

First QC Date

February 14, 2011

Last Update Submit

December 23, 2015

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Westerns / activation of signaling pathways (uo to two hours after treatment)

    04/01/2016

Study Arms (1)

Group 1

Lean and obese, diabetic and non diabetics

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

diabetic or nondiabetic lean and obese subjects

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christos Mantzoros, MD DSc

    VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2011

First Posted

February 16, 2011

Study Start

April 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 24, 2015

Record last verified: 2015-12

Locations

US(1)