In Vivo Leptin Signaling in Humans After Acute Leptin Administration
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01275053|
Recruitment Status : Completed
First Posted : January 12, 2011
Results First Posted : August 3, 2017
Last Update Posted : October 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lean Obese Obese Diabetics||Drug: leptin||Phase 1|
Screening Visit During this visit, you will have a complete medical history taken and have a physical examination performed by one of the study physicians. You will also have your height and weight measured. You will have a blood drawn (approximately 2 tablespoons)and will have an electrocardiogram (EKG). At the screening visit you will also meet with a dietician who will review your food preferences with you in order to design the meals that you will receive as part of the study.
Study Day #1: You will pick up your meals designed with the dietician. You will be provided with meals for 48 hours prior to your fat biopsy. These meals will be designed by the dietician based upon what you like to eat. You will also have your Resting Metabolic Rate Measured.
Study Day #2: A nurse will will insert two intravenous catheters (IV) into a medium size vein in each of your forearms. You will then have two fat and muscle thigh biopsy. One before and one after leptin is given. You will stay in the hospital for three hours of observation. During this time you will have your Resting Metabolic Rate measured and then you will be provided with a meal.
Study Day #3: Seven to ten days after the biopsy, you will be asked to return to the hospital so that the surgeon can inspect the wound.
Your participation in this study will involve 3 study visits, which will be spread out over 3-4 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||In Vivo Leptin Signaling in Humans After Acute Leptin Administration|
|Study Start Date :||July 2002|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||January 2017|
- Leptin Signaling [ Time Frame: Baseline and 30 minutes ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275053
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Christos s Mantzoros, MD||Beth Israel Deaconess Medical Center|