Impact of Metabolic Health on Sperm Epigenetic Marks in Humans
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.
Conditions:
🦠 Overweight 🦠 Type 2 Diabetes Mellitus 🦠 Type 1 Diabetes Mellitus
🗓️ Study Start (Actual) 1 May 2018
🗓️ Primary Completion (Estimated) 1 July 2024
✅ Study Completion (Estimated) 1 July 2024
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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 Criteria:

    • * 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
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 11 October 2018
  • First Submitted that Met QC Criteria 28 February 2019
  • First Posted 4 March 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 August 2023
  • Last Update Posted 3 August 2023
  • Last Verified August 2023