Impact of Metabolic Health on Sperm Epigenetic Marks in Humans
1 other identifier
interventional
40
1 country
1
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 focused in glycemic intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 11, 2018
CompletedFirst Posted
Study publicly available on registry
March 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
February 6, 2026
February 1, 2026
8.2 years
October 11, 2018
February 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Spermatozoa concentration
Sperm will be assessed for concentration, reported as total yield (millions per ml)
1 year
Secondary Outcomes (2)
Sperm DNA methylation, reported as genomic location of regions with methylation altered in response to intervention
1 year
RNA Sequencing
1 year
Study Arms (3)
Lifestyle Intervention
EXPERIMENTAL20 overweight men with T1D or T2D will undergo an intensive 3 month lifestyle intervention program aimed at improving metabolic health, glycemic control, and body weight.
No-Intervention Controls
ACTIVE COMPARATOR10 overweight men with T1D or T2D will be assessed at baseline and at 3 months. They will not participate in a lifestyle intervention.
Healthy Controls
ACTIVE COMPARATOR10 healthy men will be assessed at baseline and at 3 months. They will not participate in a lifestyle intervention.
Interventions
Participants will undergo a 12-week multidisciplinary program for weight control and intensive diabetes management. The program includes adjustments to diabetes medications to enhance weight reduction and improve glycemia, dietary modification, and activity instructions.
Participants will not undergo an intervention.
Eligibility Criteria
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;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Related Publications (2)
Sales VM, Ferguson-Smith AC, Patti ME. Epigenetic Mechanisms of Transmission of Metabolic Disease across Generations. Cell Metab. 2017 Mar 7;25(3):559-571. doi: 10.1016/j.cmet.2017.02.016.
PMID: 28273478BACKGROUNDSu L, Dreyfuss JM, Ferraz Bannitz R, Wolfs D, Hansbury G, Richardson L, Charmant C, Patel J, Ginsburg ES, Racowsky C, Fore R, Efthymiou V, Desmond J, Goldfine A, Ferguson-Smith A, Pan H, Hivert MF, Isganaitis E, Patti ME. Type 2 diabetes impacts DNA methylation in human sperm. Clin Epigenetics. 2025 Mar 20;17(1):49. doi: 10.1186/s13148-025-01853-9.
PMID: 40108650DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2018
First Posted
March 4, 2019
Study Start
May 1, 2018
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
February 6, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share