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Completed

NCT Number: NCT00657605

Effects of Human Leptin Replacement

This study will test the hypothesis that leptin contributes to the regulation of the dynamics of human endocrine function.

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Key information

Conditions

Obesity Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami Miller School of Medicine, Center on Pharmacogenomics

Miami, Florida, 33136, United States

About this study

The study aims to elucidate the role of leptin in the regulation of human endocrine function approached by a carefully designed, prospective clinical study of the rapidly-sampled dynamics of endocrine rhythms during the course of leptin-replacement treatment in the only three adult individuals identified in the world so far who are leptin-naive due to a functional leptin gene mutation. A study of leptin-naive subjects avoids all confounding factors and pitfalls, because the only bioactive leptin to which they will be exposed is the exogenously administered recombinant protein. Thus, this proposal will permit us to ascertain the endocrine effects of human leptin.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Congenital leptin deficiency (these are only 3 adult individuals in the world that have been identified as leptin-naïve thus far).

Exclusion criteria

  • Pregnant, trying to become pregnant, breast-feeding an infant or sexually active women, not using contraception.
  • Subjects with hemoglobin levels below 12 g/dl.
  • Subjects whose body contains a ferromagnetic implanted device that might produce a safety hazard during fMRI.

Treatment and study plan

Recombinant methionyl human leptin

Drug

Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss), indeterminate duration.

Other names: Metreleptin, r-metHuLeptin

Primary outcomes

  1. Change in Weight

    Time frame: Baseline, 107 months

Secondary outcomes

  1. Change in Glucose Levels

    Time frame: Baseline, 107 months

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2001
Primary completion
2010
Study completion
2010
First posted
Apr 14, 2008
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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