Hypogonadism in Young Men With Type 2 Diabetes

• Sponsor: State University of New York at Buffalo (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01155518
• Collaborator: American Diabetes Association (Other)
• Enrollment: 5
• Location: 1
• Arms: 6
• Duration (Months): 42
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypogonadotropic Hypogonadism; Type 2 Diabetes	Drug: testosterone; Drug: clomiphene; Drug: placebo; Drug: placebo	Phase 2

Detailed Description

This project will study young men with type 2 diabetes. We have shown that half of these men have low testosterone levels. This can lead to 1) Low muscle mass; 2) more fat mass; 3) insulin resistance; 4) low sperm count and 5) increased inflammation (that increases the risk of heart disease). This project will study these consequences in detail and also the possibility of reversing them with treatment. Information from this project will be useful in planning of future studies that will evaluate the effect of treatment of low testosterone on mortality, heart disease and stroke.

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effect of Hypogonadotropic Hypogonadism and Replacement With Clomiphene Citrate and Testosterone on Insulin Sensitivity, Body Composition, Inflammation, Sexual Function and Spermatogenesis in Young Type 2 Diabetic Men
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: testosterone intramuscular injections every 2 weeks	Drug: testosterone; intramuscular every 2 weeks
Experimental: clomiphene oral drug thrice a week	Drug: clomiphene; thrice a week
Placebo Comparator: placebo for testosterone placebo for testosterone arm	Drug: placebo; intramuscular saline injections every 2 weeks
Placebo Comparator: placebo for clomiphene oral placebo for clomiphene arm	Drug: placebo; oral
No Intervention: eugonadal obese obese men with normal testosterone level
No Intervention: lean healthy lean men (control)

Outcome Measures

Primary Outcome Measures

1. Insulin Resistance [6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• T2D Males with age 18-40 years

Exclusion Criteria:

1. planning to have children in the next one year

2. Use of androgens, CC, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months;

3. PSA > 4ng/ml, symptoms of severe BPH, prostate nodule or severe enlargement on digital rectal examination or h/o prostatic carcinoma

4. Hemoglobin A1c > 8%

5. Hematocrit > 50%

6. History of obstructive sleep apnea

7. Congestive heart failure

8. Use of thiazolidinediones or exenatide

9. currently suffering from depression, with or without treatment

10. history of severe depression in the past which needed hospitalization

11. currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition

12. Coronary event or procedure in the previous 6 months

13. Hepatic disease (transaminase > 3 times normal) or cirrhosis

14. Renal impairment (serum creatinine > 1.5)

15. HIV or Hepatitis C positive status

16. Participation in any other concurrent clinical trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Millard Fillmore Gates Hospital	Buffalo	New York	United States	14209

Sponsors and Collaborators

• State University of New York at Buffalo
• American Diabetes Association

Investigators

• Principal Investigator: Sandeep Dhindsa, MBBS, SUNY at Buffalo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: sandeep dhindsa, Assoc Prof of Medicine, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT01155518
• Other Study ID Numbers: 1-10-JF-13
• First Posted: Jul 1, 2010
• Last Update Posted: Oct 4, 2019
• Last Verified: Oct 1, 2019

• Keywords provided by sandeep dhindsa, Assoc Prof of Medicine, State University of New York at Buffalo: hypogonadism; diabetes; spermatogenesis; insulin resistance
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2; Hypogonadism; Clomiphene; Testosterone

Study Results

Participant Flow

Arm/Group Title	Testosterone	Clomiphene	Placebo for Testosterone	Placebo for Clomiphene	Eugonadal Obese	Control
Arm/Group Description	intramuscular injections every 2 weeks testosterone: intramuscular every 2 weeks	oral drug thrice a week clomiphene: thrice a week	placebo for testosterone arm placebo: intramuscular saline injections every 2 weeks	oral placebo for clomiphene arm placebo: oral	men with obesity and normal testosterone levels	lean healthy men with normal testosterone levels
Period Title: Overall Study
STARTED	1	1	0	0	1	2
COMPLETED	1	0	0	0	1	2
NOT COMPLETED	0	1	0	0	0	0

Baseline Characteristics

Arm/Group Title	Testosterone	Clomiphene	Placebo for Testosterone	Placebo for Clomiphene	Eugonadal Obese	Lean	Total
Arm/Group Description	intramuscular injections every 2 weeks testosterone: intramuscular every 2 weeks	oral drug thrice a week clomiphene: thrice a week	placebo for testosterone arm placebo: intramuscular saline injections every 2 weeks	oral placebo for clomiphene arm placebo: oral	obese men with normal testosterone level	healthy lean men (control)	Total of all reporting groups
Overall Participants	1	1	0	0	1	2	5
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34 (0)	30 (0)	36 (0)	21 (1)	30 (7)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 NaN	0 NaN	0 0%	0 0%	0 0%
Male	1 100%	1 100%	0 NaN	0 NaN	1 100%	2 100%	5 100%
Region of Enrollment (participants) [Number]
United States	1 100%	1 100%	1 Infinity	2 Infinity	5 500%

Outcome Measures

1. Primary Outcome

Title	Insulin Resistance
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

study terminated

Arm/Group Title	Testosterone	Clomiphene	Placebo for Testosterone	Placebo for Clomiphene	Eugonadal Obese	Normal Lean
Arm/Group Description	intramuscular injections every 2 weeks testosterone: intramuscular every 2 weeks	oral drug thrice a week clomiphene: thrice a week	placebo for testosterone arm placebo: intramuscular saline injections every 2 weeks	oral placebo for clomiphene arm placebo: oral	normal testosterone men	control
Measure Participants	0	0	0	0	0	0

Adverse Events

Arm/Group Title	Testosterone		Clomiphene		Placebo for Testosterone		Placebo for Clomiphene		Eugonadal Obese		Control
Arm/Group Description	intramuscular injections every 2 weeks testosterone: intramuscular every 2 weeks		oral drug thrice a week clomiphene: thrice a week		placebo for testosterone arm placebo: intramuscular saline injections every 2 weeks		oral placebo for clomiphene arm placebo: oral		obese men with normal testosterone levels		healthy lean men with normal testosterone levels
All Cause Mortality
	Testosterone		Clomiphene		Placebo for Testosterone		Placebo for Clomiphene		Eugonadal Obese		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)		0/0 (NaN)		0/0 (NaN)		0/1 (0%)		0/2 (0%)
Serious Adverse Events
	Testosterone		Clomiphene		Placebo for Testosterone		Placebo for Clomiphene		Eugonadal Obese		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)		0/0 (NaN)		0/0 (NaN)		0/1 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Testosterone		Clomiphene		Placebo for Testosterone		Placebo for Clomiphene		Eugonadal Obese		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)		0/0 (NaN)		0/0 (NaN)		0/1 (0%)		0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.