NCT00691158

Brief Summary

The purpose of this study is to identify how certain parts of the brain that help control body weight respond to an infusion of hormones called leptin and amylin.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2008

Completed
16.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

December 16, 2022

Status Verified

December 1, 2022

Enrollment Period

18.5 years

First QC Date

June 2, 2008

Last Update Submit

December 14, 2022

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • To measure the fMRI response in the hypothalamus and brainstem, and whole brain, to intravenous leptin, pramlintide, combination leptin and pramlintide, and saline control.

    measurements at each study time are include fMRI, blood draws and Visual Analog Score.

    over 90 minutes

Secondary Outcomes (1)

  • Timed blood samples during infusion will establish the time course for peak levels of infused hormones as well as detectable changes in insulin and glucose levels.

    over 90 minutes

Study Arms (4)

1- Normal Saline

PLACEBO COMPARATOR

4.7 mls normal saline IV bolus

Drug: Placebo (Normal Saline)

2 Metreleptin

ACTIVE COMPARATOR

IV Leptin bolus

Drug: 2 Metreleptin

3 Pramlintide

ACTIVE COMPARATOR

IV Pramlintide bolus at Timpoint +0 and +30 minutes

Drug: Pramlintide (Amylin)

4 Leptin plus Pramlintide

ACTIVE COMPARATOR

leptin and pramlintide IV bolus injection at timpoints 0 and +30 minutes

Drug: Leptin plus Pramlintide

Interventions

Pramlintide (Amylin)DRUG

4.7 mls of Amylin 15mcg/ml IV bolus.

Also known as: Amylin
3 Pramlintide
Placebo (Normal Saline)DRUG

4.7 mls normal saline IV bolus x1

Also known as: Placebo
1- Normal Saline
2 MetreleptinDRUG

Receive .06mg/kg of metreleptin IV bolus x1

Also known as: Leptin
2 Metreleptin
Leptin plus PramlintideDRUG

receive leptin IV bolus x1 and pramlintide bolus at Timepoint +0 and +30 minutes.

Also known as: Leptin and Amylin
4 Leptin plus Pramlintide

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 year to 45 years of age
  • MI 18 to 25 kg/m2 or ≥ 30 kg/m2
  • At maximal lifetime weight
  • Weight stable for at least 3 months

You may not qualify if:

  • Those with a major medical illness or who require prescription medication, including: cancer, coronary artery disease, hypertension, and diabetes.
  • Subjects taking psychiatric or centrally-acting (CNS) medications or who are diagnosed with a psychiatric or neurological illness, including:
  • depression
  • anorexia
  • bulimia
  • seizure disorder.
  • Exercise \> 30 minutes, 3 times a week
  • Alcohol consumption \> 2 drinks / day
  • Weight \> 350 lbs (159 kg) (weight limit for MR machine)
  • Illicit drug use
  • Pregnancy
  • Extreme dietary habits as determined by a GCRC nutritionist: very high or low dietary carbohydrate or fat intakes
  • Those with a contraindication to exposure to strong magnetic fields: presence of metal in the body such as body piercing, shrapnel, cardiac pacemakers or aneurysm clips
  • Those with claustrophobia
  • Anaphylaxis and known hypersensitivity to E. coli-derived proteins
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

pramlintideIslet Amyloid PolypeptideSaline SolutionLeptin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsAmyloidogenic ProteinsAmyloidProteinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAdipokinesIntercellular Signaling Peptides and ProteinsBiological Factors

Study Officials

  • Jonathan Q. Purnell, M.D.

    OHSU - Center for the Study of Weight Regulation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 2, 2008

First Posted

June 5, 2008

Study Start

January 1, 2006

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

December 16, 2022

Record last verified: 2022-12

Locations

US(1)