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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Spermatozoa concentration
Secondary outcome measures
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
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
96 Previous Clinical Trials
26,533 Total Patients Enrolled
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the enrollment capacity for this research trial?
"Affirmative. Clinicaltrials.gov records demonstrate that this medical investigation, first posted on May 1st 2018, is still open for recruitment. 40 patients are necessary to be sourced from a single clinic."
Answered by AI
Are there vacancies for participants to join this study?
"Affirmative. Clinicaltrials.gov confirms that this medical trial is recruiting participants and commenced on May 1st, 2018 with an update made in September 15th 2022. This research project needs 40 patients to be enlisted from a single site."
Answered by AI
Are there certain criteria for individuals to participate in this clinical trial?
"For those between 18 and 65 years of age, this medical trial is seeking 40 participants who have been diagnosed with diabetes mellitus type 2 by an endocrinologist. Additionally, individuals must be male; possess a Hemoglobin A1c level more than 7%; present an overweight BMI exceeding 25 kg/m2; commit to providing informed consent along with sperm specimens 3 months apart; and demonstrate their willingness to abide by the study's procedures."
Answered by AI
Do individuals older than 40 years of age qualify for the research project?
"Patients wishing to enroll in this trial must fall within the 18-65 year age range, as specified by the selection criteria."
Answered by AI
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