Status:
RECRUITING
Impact of Metabolic Health on Sperm Epigenetic Marks in Humans
Lead Sponsor:
Joslin Diabetes Center
Conditions:
Overweight
Type 2 Diabetes Mellitus
Eligibility:
MALE
18-65 years
Phase:
NA
Brief 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 foc...
Detailed Description
Parental history of diabetes confers substantial individual risk for development of obesity and diabetes. Obesity risk can be transmitted across generations, from parents or grandparents to children. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03860558
Start Date
May 1 2018
End Date
July 1 2025
Last Update
August 9 2024
Active Locations (1)
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1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215