Hypogonadotropic Hypogonadism Clinical Trial
Official title:
Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism
Verified date | April 2017 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators are doing this research study to look at the relationship between
testosterone (the main sex hormone in men) and insulin (the hormone that controls blood
sugar levels) in men with Idiopathic Hypogonadotropic Hypogonadism (IHH).
The investigators hypothesize that normalizing testosterone levels in men with IHH enhances
insulin sensitivity, reduces visceral fat, increases lean body mass, and improves the lipid
profile.
Status | Terminated |
Enrollment | 7 |
Est. completion date | September 1, 2010 |
Est. primary completion date | September 1, 2010 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of idiopathic hypogonadotropic hypogonadism or Kallmann Syndrome - mean testosterone level less than 300 ng/dl - stable weight for the previous 3 months (no weight change greater than or equal to 10 lbs) - normal serum TSH - normal serum prolactin levels Exclusion Criteria: - Type 2 diabetes mellitus - history of diabetes in parents - sleep apnea - bleeding disorder - seeking fertility - 2 or more cardiovascular risk factors: smoking, hypertension, diabetes, dyslipidemias, family history of cardiovascular disease before age 60. - history of previous cardiovascular event: myocardial infarction, unstable angina, cerebro-vascular accident. - illicit drug use/alcohol use (>4 drinks per day) |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in glucose tolerance | Response to 75 g glucose load | Change between baseline and 3 months | |
Primary | Change in insulin sensitivity | IV glucose tolerance test | Change between baseline and 3 months | |
Secondary | Change in visceral fat | Assessed by CT of abdomen | Change between baseline and 3 months | |
Secondary | Change in resting energy expenditure | Assessed by metabolic monitor | Change between baseline and 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01438073 -
Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling
|
Phase 1 | |
Completed |
NCT01403532 -
Sequential Therapy for Hypogonadotropic Hypogonadism
|
Phase 4 | |
Recruiting |
NCT00456274 -
Baselines in Reproductive Disorders
|
N/A | |
Terminated |
NCT05205837 -
A Randomized, Double-blinded, Clinical, Placebo-controlled Trial on the Effects of Therapy With Letrozole and hUman Choriongonadotropin in Male Hypogonadism Induced by Illicit Use of Anabolic Androgenic Steroids- The LUCAS Trial
|
Phase 4 | |
Completed |
NCT02908074 -
A 6 Month Safety Extension Study of MBGS205
|
Phase 2 | |
Completed |
NCT05752591 -
Hypothalamic-pituitary Dysfunction in Diabetes
|
||
Completed |
NCT02730169 -
Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
|
Phase 2 | |
Completed |
NCT02110368 -
Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions
|
Phase 3 | |
Recruiting |
NCT01601171 -
Genetics of Reproductive Disorders (Including Kallmann Syndrome) and Cleft Lip and/or Palate
|
||
Completed |
NCT01623570 -
Clinical Outcomes in WHO Type I Anovulatory Women Using r-hFSH+r-hLH in a 2:1 Ratio or hMG-HP
|
N/A | |
Terminated |
NCT00328926 -
Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])
|
Phase 4 | |
Completed |
NCT01438034 -
Kisspeptin in the Evaluation of Delayed Puberty
|
Phase 1 | |
Completed |
NCT04456296 -
A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
|
Phase 4 | |
Recruiting |
NCT00914823 -
Kisspeptin Administration in the Adult
|
Phase 1 | |
Terminated |
NCT01155518 -
Hypogonadism in Young Men With Type 2 Diabetes
|
Phase 2 | |
Completed |
NCT00697814 -
Clomiphene in Males With Prolactinomas and Persistent Hypogonadism
|
Phase 2 | |
Active, not recruiting |
NCT00351416 -
Letrozole Treatment in Normal and GnRH Deficient Women
|
Phase 2/Phase 3 | |
Recruiting |
NCT05971836 -
The Molecular Basis of Inherited Reproductive Disorders
|
||
Recruiting |
NCT02705014 -
Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome
|
N/A | |
Recruiting |
NCT04648969 -
Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism
|
Phase 2 |