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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 belowSelect...
I am a man aged between 18 and 65.
Select...
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:Select...
I am currently using nitrates or guanylate cyclase stimulators.
Select...
My kidney function is severely reduced.
Select...
I have a current infection in my urinary or genital area.
Select...
I use steroid hormones, but not for breathing problems.
Select...
I have heart failure that affects my daily activities.
Select...
My liver isn't working well, shown by high ALT or AST, low albumin, or high bilirubin.
Select...
I have severe damage to my retina due to diabetes.
Select...
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
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 • NCT0015141135%
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
9%
musculoskeletal
5%
vaginal infection
5%
dizziness
5%
hair loss
5%
dental issues
4%
fatigue
4%
flatulence
2%
bladder infection
100%
80%
60%
40%
20%
0%
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.
Find a Location
Who is running the clinical trial?
Joslin Diabetes CenterLead Sponsor
97 Previous Clinical Trials
26,524 Total Patients Enrolled
15 Trials studying Obesity
714 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You smoke cigarettes.I am currently using nitrates or guanylate cyclase stimulators.You are currently misusing alcohol or drugs.You have high levels of prolactin in your blood, measured at over 18 ng/ml.My kidney function is severely reduced.Undescended testicleI have a current infection in my urinary or genital area.You weigh more than what is considered healthy for your height.I am a man aged between 18 and 65.I use steroid hormones, but not for breathing problems.I have heart failure that affects my daily activities.I have been diagnosed with diabetes by an endocrinologist.My liver isn't working well, shown by high ALT or AST, low albumin, or high bilirubin.Your total testosterone level is less than 250 ng/dl.I have severe damage to my retina due to diabetes.I haven't had cancer or chemotherapy in the last 5 years, except for skin cancer that did not spread.I haven't had a heart attack or heart surgery in the last 6 months.Your HbA1c level is higher than 7% if you have diabetes.My testicular volume is less than 12 mL.Your estradiol level is higher than 42 pg/ml.
Research Study Groups:
This trial has the following groups:- Group 1: Lifestyle Intervention
- Group 2: No-Intervention Controls
- Group 3: Healthy Controls
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.