NCT03860558Active, not recruiting
Impact of Metabolic Health on Sperm Epigenetic Marks in Humans
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 11 Oct 2018
- Start date
- 1 May 2018
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Joslin Diabetes Center
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT03860558
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 May 2018 to the primary completion date, 1 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
- 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;
- Cancer (except localized non-melanoma skin cancers) or use of chemotherapy agents within 5 years;
- Use of steroid hormones (including testosterone), other than inhalers for reactive airway disease
Lab values
- 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;
Other
- Severe diabetic retinopathy;
- 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;
- Use of nitrates or guanylate cyclase stimulators;
Who the study is looking for
- 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)
Age in the registry: 18 years to 65 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Joslin Diabetes Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.