Evaluating how metabolic health affects sperm epigenetics in overweight men with diabetes

Impact of Metabolic Health on Sperm Epigenetic Marks in Humans

This study is testing if a three-month lifestyle change aimed at better blood sugar control can improve sperm health in overweight men with diabetes.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Male
• Sponsor: Joslin Diabetes Center (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT03860558 on ClinicalTrials.gov

What this trial studies

This study aims to assess whether a three-month lifestyle intervention focused on glycemic control can improve epigenetic markers in the sperm of overweight men diagnosed with type 1 or type 2 diabetes. It explores the relationship between metabolic health and epigenetic changes, which may influence the risk of obesity and diabetes in future generations. Participants will provide sperm samples before and after the intervention to analyze changes in epigenetic patterns. The study seeks to understand how environmental factors and metabolic conditions can affect gene expression in sperm.

Who should consider this trial

Good fit: Ideal candidates for this study are overweight men aged 18-65 with a confirmed diagnosis of type 1 or type 2 diabetes and an HbA1c greater than 7%.

Not a fit: Patients with severe chronic kidney disease, hepatic disease, or significant cardiovascular issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into how lifestyle changes can positively influence sperm health and potentially reduce the risk of diabetes and obesity in offspring.

How similar studies have performed: While there is existing research on epigenetic changes in animal models, this study represents a novel approach in humans, focusing on the impact of metabolic health on sperm epigenetics.

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

Where this trial is running

Boston, Massachusetts

• Joslin Diabetes Center — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Study coordinator: Mary E Patti, MD

Conditions: Overweight, Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus