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OpenTrials
Completed

NCT Number: NCT00659828

Effects of Leptin Replacement in Children

To assess the endocrine and immune effects of leptin replacement in leptin-deficient children, from a consanguineous family. The hypothesis is that leptin replacement will have significant effects on 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

5 year–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami, Center on Pharmacogenomics

Miami, Florida, 33132, United States

About this study

The proposed study of the treatment of a child with congenital leptin deficiency will permit to elucidate key aspects of human endocrine function, and will give new insights on the role of leptin in human endocrine regulation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children with a functional leptin gene mutation from a consanguineous Turkish family. Only one leptin-naïve child from this family is alive and eligible.

Exclusion criteria

  • N/A

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. Weight

    Time frame: Baseline, 58 months

Secondary outcomes

  1. Glucose Levels

    Time frame: Baseline, 58 months

  2. Bone Mineral Density

    Time frame: Baseline, 58 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
2005
Primary completion
2010
Study completion
2010
First posted
Apr 16, 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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