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NCT01275053 · ClinicalTrials.gov registry record · Phase 1
In Vivo Leptin Signaling in Humans After Acute Leptin Administration
A Phase 1 study of Obese and Lean, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT01275053: Completed Phase 1 study of Obese and Lean, sponsored by Beth Israel Deaconess Medical Center.
NCT01275053 is a Phase 1 study of Obese and Lean that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 12 participants, below the 211-participant average among 27 other Obese trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01275053, a Phase 1 study of Obese and Lean, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to help us to better understand how leptin regulates blood sugar levels. Leptin is a recently discovered hormone, which is made in fat cells. Leptin is secreted by fat and acts as a signal to the brain to decrease appetite and influences how the body regulates blood sugar levels. A synthetic form of leptin (A-100), an investigational drug and has not yet been approved by the Food and Drug Administration (FDA), will be administered to participants in this study. The expected duration of your participation is 3 study visits, which will be spread over 3-4 weeks. This study involves having fat and muscle biopsies after receiving leptin under local anesthesia in the General Clinical Research Center (GCRC), surgical unit, and/or Endocrinology exam room at the Beth Israel Deaconess Medical Center.
Primary Outcome
Leptin signaling is assessed before and 30 minutes after in vivo metreleptin administration. The primary outcome was p-STAT3/STAT3 in biopsies (fat tissue) before and 30 minutes after in vivo metreleptin administration. The p-STAT3/STAT3 before metreleptin administration was given the value 1, and the p-STAT3/STAT3 30 minutes after in vivo metreleptin administration was given the value showing the fold change compared to p-STAT3/STAT3 before metreleptin administration.
Conditions Studied
Interventions
- DRUG leptin
Study Locations (1)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2002-07 |
| Est. Completion | 2017-01 |
| Phase | Phase 1 |
What the finished NCT01275053 record still lists
NCT01275053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 211-participant average among 27 other Obese trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Obese appearing as the primary indexed condition, and to 1 intervention - of which leptin is the first listed.
NCT01275053 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01275053 about?
NCT01275053 is a clinical study titled "In Vivo Leptin Signaling in Humans After Acute Leptin Administration". The purpose of this research study is to help us to better understand how leptin regulates blood sugar levels. Leptin is a recently discovered hormone, which is made in fat cells. Leptin is secreted by fat and acts as a signal to the brain to decrease appetite and influences how the body regulates b...
What is the current status of trial NCT01275053?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2002-07. Estimated completion is 2017-01.
What conditions does trial NCT01275053 study?
This clinical trial studies the following conditions: Obese, Lean, Obese Diabetics.
What interventions are being tested in trial NCT01275053?
The interventions under investigation include: leptin (DRUG).
Who is sponsoring clinical trial NCT01275053?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01275053 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obese
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01275053's enrollment target sits among peer trials
12 28th of 27 the lowest of 27 other Obese trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obese trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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