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Can a healthier lifestyle improve sperm quality in men with diabetes?

NCT ID NCT03860558

Knowledge-focused Sponsor: Joslin Diabetes Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how being overweight and having type 1 or type 2 diabetes may change genetic markers in sperm. Researchers will test if a 3-month lifestyle or blood sugar program can improve these markers. About 40 men will provide sperm samples before and after the program.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2018

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Overweight type 1 diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Overweight Type 1 diabetes mellitus Type 2 diabetes mellitus

Contacts and locations

Locations

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.