RECRUITING

Impact of Metabolic Health on Sperm Epigenetic Marks in Humans

Conditions

Overweight Type 2 Diabetes Mellitus Type 1 Diabetes Mellitus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Impact of Metabolic Health on Sperm Epigenetic Marks in Humans

Quick Facts

Study Start:2018-05-01

Study Completion:2025-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03860558

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

Mary E Patti, MD

CONTACT

6173092635

mary.elizabeth.patti@joslin.harvard.edu

Elvira Isganaitis, MD

CONTACT

elvira.isganaitis@joslin.harvard.edu

Study Locations (Sites)

Joslin Diabetes Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Joslin Diabetes Center

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

Study Start Date2018-05-01

Study Completion Date2025-07-01

Study Record Updates

Study Start Date2018-05-01

Study Completion Date2025-07-01

Terms related to this study

Additional Relevant MeSH Terms

Overweight
Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus