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Completed

NCT Number: NCT02023918

Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes

Growth hormone is well known to cause changes in glucose regulation. People with Laron syndrome are born without the growth hormone receptor and are protected from diabetes. Mice who are engineered without the growth hormone receptor are similarly protected from diabetes. Conversely, people who have excessive amounts of growth hormone, such as patients with acromegaly, have an increased risk for type 2 diabetes. In acromegaly patients, treatment with pegvisomant, a medication that reduces insulin like growth factor-1 by blocking the growth hormone receptor, significantly improves insulin resistance. Pegvisomant has not been explored as a possibility for the treatment of type 2 diabetes or insulin resistance in people without acromegaly. In this study, the investigators hope to study the metabolic effects of pegvisomant on people who have insulin resistance but not diabetes. Pegivosmant is expected to improve insulin resistance in the liver, fat and muscle as well as decrease serum free fatty acids.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Francisco General Hospital

San Francisco, California, 94110, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI between 18-35
  • Homeostatic model assessment - insulin resistance (HOMA-IR) >2.77
  • Able to administer daily subcutaneous injections of pegvisomant

Exclusion criteria

  • Pregnancy
  • Breastfeeding in the last 6 months
  • Liver function tests greater than 3x the upper limits of normal
  • unstable diet over the last 3 months
  • unstable weight over the last 6 months
  • unstable lipid lowering regimen
  • diabetes - type 1 or type 2
  • History of major gastrointestinal surgery
  • History of pancreatic, liver, biliary, or intestinal disease
  • Fasting blood glucose >126
  • Fasting triglycerides>500
  • A1c>6.5

Treatment and study plan

Pegvisomant

Drug

Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.

Other names: Somavert

Primary outcomes

  1. Insulin Sensitivity

    Time frame: 28 days

    Investigators will measure insulin sensitivity via hyperinsulinemic euglycemic clamp prior to the initiation of the study medication and then again at the end of the 28 days to evaluate the effect of pegvisomant on insulin sensitivity and reported as HOMA-IR.

    HOMA-IR was derived from fasting insulin and fasting glucose by the calculation: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5

Secondary outcomes

  1. Lipolysis

    Time frame: 28 days

    Treatment with pegvisomant is expected to alter lipolysis. To assess this investigators will do fasting and steady state stable isotope measurements prior to treatment with pegvisomant and at day 28 after treatment with pegvisomant.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • San Francisco General Hospital

Registry information

Official study title

Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Insulin Resistance But Without Diabetes

Acronym: PEGIR

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 30, 2013
Registry last updated
Apr 24, 2017

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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