Impact of Metabolic Health on Sperm Epigenetic Marks in Humans
Running, not enrolling · Not applicable
Conditions studied: Overweight, Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT03860558
- Run by
- Joslin Diabetes Center
- People needed
- 40
- Starts
- 2018-05-01
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-02-06
Who can join
Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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 it is running
- Joslin Diabetes Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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