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Behavioural Intervention

Lifestyle Intervention for Diabetes

N/A

Recruiting

Research Sponsored by Joslin Diabetes Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male, age 18-65 years

Type 1 or type 2 diabetes diagnosis confirmed by an endocrinologist (for participants in the diabetes groups)

Must not have

Use of nitrates or guanylate cyclase stimulators

Chronic kidney disease stage 4 or 5 (including end-stage renal disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a lifestyle intervention can improve epigenetic markers in obese men with type 1 or type 2 diabetes.

Who is the study for?

Men aged 18-65 with type 1 or type 2 diabetes, overweight (BMI >25), and an HbA1c level over 7% can join this study. They must be able to follow the study plan and provide sperm samples. Men with severe diabetic eye disease, recent heart issues, cancer treatments within five years, certain hormone disorders, smoking habits, serious infections or organ failures are not eligible.

What is being tested?

The trial is testing if a lifestyle program focused on managing blood sugar levels can improve epigenetic markers in sperm of overweight men with diabetes. Participants will either receive this intervention or no intervention for comparison over three months.

What are the potential side effects?

Since the interventions involve lifestyle changes rather than medication, side effects may include typical exercise-related injuries or stress. No direct medical side effects are expected from the lifestyle intervention itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man aged between 18 and 65.

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I have been diagnosed with diabetes by an endocrinologist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently using nitrates or guanylate cyclase stimulators.

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My kidney function is severely reduced.

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I have a current infection in my urinary or genital area.

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I use steroid hormones, but not for breathing problems.

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I have heart failure that affects my daily activities.

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My liver isn't working well, shown by high ALT or AST, low albumin, or high bilirubin.

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I have severe damage to my retina due to diabetes.

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My testicular volume is less than 12 mL.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Spermatozoa concentration

Secondary study objectives

RNA Sequencing

Sperm DNA methylation, reported as genomic location of regions with methylation altered in response to intervention

Side effects data

From 2008 Phase 2 trial • 114 Patients • NCT00151411

35%

Diarrhea

22%

headache/migraine

22%

common cold/respiratory tract infection

16%

nausea and/or vomiting

15%

flu

13%

dysmenorrhea/cramps

11%

stomach/abdominal pain or discomfort

musculoskeletal

vaginal infection

dizziness

hair loss

dental issues

fatigue

flatulence

bladder infection

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Metformin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Lifestyle InterventionExperimental Treatment1 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.

Group II: No-Intervention ControlsActive Control1 Intervention

10 overweight men with T1D or T2D will be assessed at baseline and at 3 months. They will not participate in a lifestyle intervention.

Group III: Healthy ControlsActive Control1 Intervention

10 healthy men will be assessed at baseline and at 3 months. They will not participate in a lifestyle intervention.

0 / 10Eligibility criteria met