Impact of Metabolic Health on Sperm Epigenetic Marks in Humans
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:
• 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)
Locations
United States
Massachusetts
Joslin Diabetes Center
RECRUITING
Boston
Contact Information
Primary
Mary E Patti, MD
mary.elizabeth.patti@joslin.harvard.edu
6173092635
Backup
Elvira Isganaitis, MD
elvira.isganaitis@joslin.harvard.edu
Time Frame
Start Date: 2018-05-01
Estimated Completion Date: 2025-07-01
Participants
Target number of participants: 40
Treatments
Experimental: Lifestyle Intervention
20 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.
Active_comparator: No-Intervention Controls
10 overweight men with T1D or T2D will be assessed at baseline and at 3 months. They will not participate in a lifestyle intervention.
Active_comparator: Healthy Controls
10 healthy men will be assessed at baseline and at 3 months. They will not participate in a lifestyle intervention.
Related Therapeutic Areas
Sponsors
Leads: Joslin Diabetes Center