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Completed

NCT Number: NCT00470990

Effect of Varying Testosterone Levels on Insulin Sensitivity in Normal and IHH Men

Type 2 diabetes is one of the most common metabolic disorders in the U.S, estimated to affect 16 million Americans. Established risk factors for this disease include obesity, increased waist/hip ratio, high insulin levels in the blood, and insulin resistance. Testosterone may play a role in developing or preventing diabetes, but we do not yet know for sure. The purpose of this research study is to determine if changing testosterone levels in men will result in changes in insulin sensitivity. Information learned form this research study may have important public health implications and may point to new strategies for treating or preventing diabetes.

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Key information

Conditions

Hypogonadism Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorder of Sex Development, 46,XY Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Kallmann Syndrome Male Urogenital Diseases Urogenital Abnormalities Urogenital Diseases

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02143, United States

About this study

The overall aim of this study is to examine the effect of testosterone on insulin sensitivity using the models of acute and chronic hypogonadism. All subjects will be in good general health and 2 groups of men will be studied in this protocol:

  • Thirty healthy normal men aged 18-75 years with normal blood pressure, normal testosterone levels, and not taking any medications known to influence glucose homeostasis or testosterone
  • Ten adult men (over the age of 18) with idiopathic hypogonadotropic hypogonadism (IHH)and normal thyroid, adrenal, and growth hormone axes as well as normal prolactin levels and no abnormalities on imaging of the hypothalamic-pituitary region. These men will be on no medications known to influence glucose homeostasis and will have been off hormone therapy for a suitable washout period depending on the type of prior androgen replacement.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Healthy men:

Good general health,

  • Normotensive,
  • Normal testosterone levels,
  • No medications known to influence glucose homeostasis or testosterone levels

IHH men:

  • Good general health;
  • Normal thyroid, adrenal, and GH axes;
  • Normal prolactin levels;
  • No abnormalities on imaging of the hypothalamic-pituitary region;
  • No medications known to influence glucose homeostasis;
  • Must have been off hormone therapy for a suitable washout period depending on the type of prior androgen replacement

Treatment and study plan

GnRH antagonist (Acyline)

Drug

3 Subcutaneous injections (300 mcg/kg) over 36 days

Other names: IND # 62,621

Primary outcomes

  1. insulin sensitivity

    Time frame: 2 timepoints: with a normal serum testsoterone and in a castrate state of low serum testoserone

Secondary outcomes

  1. body composition

    Time frame: 2 timepoints: with a normal serum testsoterone and in a castrate state of low serum testoserone

Sponsors and collaborators

Lead sponsor

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

Nih

Collaborators

  • American Diabetes Association

Registry information

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
May 8, 2007
Registry last updated
Apr 20, 2011

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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