Hypogonadism in Young Men With Type 2 Diabetes

NCT01155518 | Terminated Phase 2 Results

• 1 other identifier: 1-10-JF-13
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Low testosterone production, known clinically as hypogonadism, appears to be common complication of type 2 diabetes, affecting one in three diabetic men. Hypogonadism is known to be associated with decreased muscle mass, increased fat mass, increased inflammation and decreased fertility. In this grant, the investigators propose to study the effects of having low testosterone on 1) insulin sensitivity, the ability of the body to handle glucose 2) fat and muscle mass at specific areas of the body 3) expression of mediators of inflammation in the blood 4) semen quality. This study will compare diabetic men (with or without hypogonadism). This study will also evaluate the effect of treatment with clomiphene (a drug that increases testosterone and sperm production) or testosterone in men with diabetes and hypogonadism. The investigators hope that this project will help us understand the state of hypogonadism in young type 2 diabetic men who are in their peak fertility years and give us insights into treatment of this condition. With the rising prevalence of type 2 diabetes in the young, this project may have implications for public health.

Conditions

Hypogonadotropic Hypogonadism; Type 2 Diabetes

Keywords

hypogonadism; diabetes; spermatogenesis; insulin resistance

Outcome Measures

Primary Outcomes (1)

• Insulin Resistance

  To compare the insulin sensitivity as measured by whole body glucose uptake during hyperinsulinemic euglycemic (HE) clamp in young T2D men with and without HH.

  6 months

Study Arms (6)

testosterone

EXPERIMENTAL

intramuscular injections every 2 weeks

Drug: testosterone

clomiphene

EXPERIMENTAL

oral drug thrice a week

Drug: clomiphene

placebo for testosterone

PLACEBO COMPARATOR

placebo for testosterone arm

Drug: placebo

placebo for clomiphene

PLACEBO COMPARATOR

oral placebo for clomiphene arm

Drug: placebo

eugonadal obese

NO INTERVENTION

obese men with normal testosterone level

lean

NO INTERVENTION

healthy lean men (control)

Interventions

testosterone DRUG

intramuscular every 2 weeks

testosterone

clomiphene DRUG

thrice a week

clomiphene

placebo DRUG

intramuscular saline injections every 2 weeks

placebo for testosterone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• T2D Males with age 18-40 years

You may not qualify if:

• planning to have children in the next one year
• Use of androgens, CC, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months;
• PSA \> 4ng/ml, symptoms of severe BPH, prostate nodule or severe enlargement on digital rectal examination or h/o prostatic carcinoma
• Hemoglobin A1c \> 8%
• Hematocrit \> 50%
• History of obstructive sleep apnea
• Congestive heart failure
• Use of thiazolidinediones or exenatide
• currently suffering from depression, with or without treatment
• history of severe depression in the past which needed hospitalization
• currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition
• Coronary event or procedure in the previous 6 months
• Hepatic disease (transaminase \> 3 times normal) or cirrhosis
• Renal impairment (serum creatinine \> 1.5)
• HIV or Hepatitis C positive status

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• American Diabetes Association: collaborator

Study Sites (1)

Millard Fillmore Gates Hospital

Buffalo, New York, 14209, United States

Location

MeSH Terms

Conditions

Hypogonadism; Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance

Interventions

Testosterone; Clomiphene

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: sandeep dhindsa
• Organization: suny buffalo

sandhindsa@yahoo.com

Study Officials

• Sandeep Dhindsa, MBBS

  SUNY at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof of Medicine

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: July 1, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 4, 2019
• Results First Posted: October 4, 2019

Record last verified: 2019-10

Locations

US (1)