NCT00050791

Brief Summary

This is a double blind placebo controlled clinical study designed to determine the effects of leptin on the changes that occur in the body during weight loss achieved by a very low calorie diet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_2 obesity

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2001

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2002

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

October 19, 2010

Status Verified

October 1, 2010

Enrollment Period

5.7 years

First QC Date

December 19, 2002

Last Update Submit

October 18, 2010

Conditions

Obesity

Keywords

ObesityWeightlossLeptinDietReducingOverweightFat

Outcome Measures

Primary Outcomes (1)

  • energy expenditure after 10% and 20% weight loss, achieved by a VLCD with or without A-100 treatment

    Testing period 2,3 and 4 after 10% and 20% weight loss

Secondary Outcomes (1)

  • endocrine and behavioral parameters

    testing period 2, 3 and 4. After 10% and 20% weight loss

Study Arms (2)

VLCD and leptin

EXPERIMENTAL

Very low calorie diet formula providing 800 calories per day and leptin treatment.

Drug: Leptin

placebo

ACTIVE COMPARATOR

Very low calorie diet and placebo treatment

Behavioral: Very Low Calorie Diet

Interventions

LeptinDRUG

Leptin is an adipocyte hormone that functions as an afferent signal in a feedback loop regulating body weight

Also known as: A-100, Recombinant-methionyl Human Leptin (r-metHuLeptin)
VLCD and leptin
Very Low Calorie DietBEHAVIORAL

placebo injections

placebo

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • (1) adult females, age 25-45 with BMI 29-45, and no other acute or chronic illnesses. Pregnant women will not be permitted to participate in the study.

You may not qualify if:

  • Chronic illnesses other the than mild forms illnesses related to obesity (hypertension, hyperlipidemia etc) that do not require medical treatment
  • Diabetes Mellitus
  • Chronic drug treatment for any medical conditions
  • Inability to give informed consent
  • Inability to give contact information (for outpatient follow up) including permanent residence, provide evidence of a stable living environment for the study period.
  • Active weight reduction of more than 7 pounds in the last 3 months
  • Weight at screening more than 6% lower than the maximal life time weight.
  • History of bleeding or blood clotting disorders.
  • Changes in smoking habits for the last 3 months.
  • Pregnancy or breast feeding in women.
  • Allergic reaction to local anesthetics
  • History of anaphylaxis or anaphylactoid-like reactions
  • Tendency to form scars (keloids) easily
  • Subjects with known hypersensitivity to E Coli-derived proteins or any other component of the A-100 preparation.
  • Irregular menses
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rockefeller University Hospital

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

ObesityWeight LossOverweightPlatelet Glycoprotein IV Deficiency

Interventions

Leptinrecombinant methionyl human leptin

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

AdipokinesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Jeffrey Friedman, MD, PHD

    Rockefeller University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2002

First Posted

December 23, 2002

Study Start

March 1, 2001

Primary Completion

November 1, 2006

Study Completion

June 1, 2009

Last Updated

October 19, 2010

Record last verified: 2010-10

Locations

US(1)