Impact of Metabolic Health on Sperm Epigenetic Marks in Humans

Launched by JOSLIN DIABETES CENTER · Feb 28, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at how being overweight and having diabetes might affect certain markers in sperm that can influence health. Specifically, researchers want to find out if a three-month program focused on improving diet and blood sugar levels can help improve these sperm markers in men with type 1 or type 2 diabetes. The goal is to see if making lifestyle changes can lead to better health outcomes for these individuals.

To participate in this study, men aged 18 to 65 who are overweight and have a confirmed diagnosis of type 1 or type 2 diabetes are eligible. Participants will need to provide sperm samples at the beginning of the study and again after three months. It's important to know that some health conditions, such as severe kidney disease or heart issues, may prevent someone from joining. If you choose to participate, you will be helping to advance our understanding of how lifestyle changes can impact men's reproductive health, especially for those managing diabetes.

Gender

MALE

Eligibility criteria

• 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 steroid hormones (including testosterone), other than inhalers for reactive airway disease