Impact of Metabolic Health on Sperm Epigenetic Marks in Humans (NCT03860558) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Impact of Metabolic Health on Sperm Epigenetic Marks in Humans
United States40 participantsStarted 2018-05-01
Plain-language summary
This study is designed to evaluate whether epigenetic markers in overweight men with type 1 diabetes (T1D) or type 2 diabetes (T2D) can be improved with a 3 month lifestyle intervention or program focused in glycemic intervention.
Who can participate
Age range18 Years – 65 Years
SexMALE
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Inclusion Criteria:
* Male, age 18-65 years
* Willing and able to provide informed consent and follow all study procedures, including providing sperm specimens 3 months apart.
* Type 1 or type 2 diabetes diagnosis confirmed by an endocrinologist (for participants in the diabetes groups)
* HbA1c \> 7% (for participants in the diabetes groups)
* Overweight (BMI \> 25 kg/m2) (for all groups, to ensure groups are similar)
Exclusion Criteria:
* Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
* Hepatic disease, including serum alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than or equal to 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin \< 3.0 g/dL; or serum bilirubin \> 2.0;
* Severe diabetic retinopathy;
* Congestive heart failure, New York Heart Association (NYHA) class II, III or IV;
* History of myocardial infarction, unstable angina or revascularization within the past 6 months;
* Active genitourinary infection;
* Testicular volume \<12 mL (assessed using Prader orchidometer);
* Hypogonadism, defined as total testosterone \<250 ng/dl;
* Hyperprolactinemia, defined as prolactin \>18 ng/ml;
* Hyperestrogenism, defined as estradiol \>42 pg/ml;
* Cryptorchidism;
* Cigarette smoking;
* Active alcohol abuse or substance abuse;
* Cancer (except localized non-melanoma skin cancers) or use of chemotherapy agents within 5 years;
* Use of nitrates or guanylate cyclase stimulators;
* Use of…