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Beta3-Adrenergic Receptor Agonist
Mirabegron + B Complex Plus Vitamin C for Brown Adipose Tissue
Phase 1
Recruiting
Led By Aaron M Cypess, M.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Insulin Resistance defined by either: HOMA-IR (a) >5.9 or (b) 2.8 < HOMA-IR < 5.9 with HDL< 51 mg/dL or Fasting Insulin >10.6 microU/mL
Cohort 3: Use of birth control such as intrauterine devices (hormonal or copper), hormonal implants, or oral contraceptives and with stable use for at least 3 months excluding exclusive use of barrier methods
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study Summary
This trial is testing if brown adipose tissue (BAT) can help the body burn energy. Healthy people ages 18-40 with a body mass index between 18 and 40 may be eligible. Participants will take 2-4 pills daily for 4 weeks.
Who is the study for?
This trial is for men and women aged 18-40 with a BMI of 18-40, who use certain birth control methods. It's not for those with significant weight changes recently, bladder issues, diabetes, high blood pressure, abnormal ECGs or heart conditions, mental health disorders incompatible with the study, substance abuse history within 5 years, excessive alcohol or nicotine use, recent pregnancy or breastfeeding (women only), medication that alters metabolism or energy expenditure.Check my eligibility
What is being tested?
Researchers are testing how brown adipose tissue (BAT) helps burn energy using mirabegron pills over four weeks. Men may receive either the drug or a placebo while all women will take mirabegron. Participants undergo various tests including scans and metabolic rate measurements in a special room. They also keep diaries of their food intake and medications.See study design
What are the potential side effects?
Potential side effects include reactions to mirabegron such as increased blood pressure and possible allergic responses if sensitive to this type of medication. The study will closely monitor participants for any adverse effects during the trial period.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have insulin resistance based on specific blood test results.
Select...
I have been using a stable form of birth control (not just condoms) for at least 3 months.
Select...
I have been using a reliable birth control method (not just condoms) for at least 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cohort 3: Change in insulin sensitivity
Cohorts 1 and 2: Change in BAT metabolic activity
Secondary outcome measures
Cohort 3: Changes in BAT metabolic activity
Cohorts 1 and 2: Changes in insulin sensitivity
Identify changes in metabolic health arising from BAT activation and/or prolonged treatment with mirabegron
Side effects data
From 2019 Phase 4 trial • 28 Patients • NCT020861887%
urinary tract infection
7%
asthma
7%
gastritis
7%
fatigue
7%
diarrhea
7%
headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Mirabegron
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Cohort 1Experimental Treatment1 Intervention
Females taking 100 mg of mirabegron
Group II: Cohort 2AActive Control1 Intervention
Males taking 200 mg mirabegron
Group III: Cohort 3AActive Control1 Intervention
Females taking 100 mg of mirabegron
Group IV: Cohort 3BPlacebo Group1 Intervention
Females taking placebo drug
Group V: Cohort 2BPlacebo Group1 Intervention
Males taking placebo drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirabegron
2008
Completed Phase 4
~18640
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,358 Previous Clinical Trials
4,315,141 Total Patients Enrolled
6 Trials studying Polycystic Ovary Syndrome
611 Patients Enrolled for Polycystic Ovary Syndrome
Aaron M Cypess, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
2 Previous Clinical Trials
260 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a problem with alcohol or drugs in the past 5 years, or you are currently using drugs.I have bladder issues like incontinence or use medication for overactive bladder.My blood pressure is above 135/85 mmHg or I am on medication for high blood pressure.I have heart, blood pressure, or kidney problems.I have an abnormal heart rhythm or take medication that affects my heart's rhythm.I've had significant radiation exposure in the past year or expect to have it.I cannot tolerate cold due to Raynaud's disease or sensitivity.I have high liver enzymes and a liver condition not related to fatty liver disease.My thyroid condition has been stable for less than a year.I have insulin resistance based on specific blood test results.I am not taking medications like beta-blockers, steroids, or certain antidepressants.I can use spironolactone while in this study.I do not have psychological conditions that would prevent me from safely participating in this study.I am taking certain antidepressants and will be closely monitored for side effects.I am currently using products that change how my body uses energy.I do not have infections or issues with wound healing at the cancer site.I have been using a stable form of birth control (not just condoms) for at least 3 months.I am a woman aged 18-40 with a BMI between 25.0-50.0.Your hemoglobin levels are lower than 13.8 g/dL if you are male, or lower than 11.3 g/dL if you are female.I haven't had an infection needing antibiotics or causing fever in the last 4 weeks.I haven't taken diabetes or insulin resistance drugs in the last 6 months.I have lost or gained more than 5% of my weight in the last 6 months.I have been using a reliable birth control method (not just condoms) for at least 3 months.You are allergic to mirabegron or similar medications.You have given blood in the past 2 months.I have diabetes with high blood sugar or I'm on diabetes medication.You currently use nicotine or tobacco products.You drink more than 2 servings of alcohol every day.I spend most of my day outside, more than 70% of it.I have sickle cell anemia or a blood clotting disorder.I am between 18 and 40 years old with a BMI between 18.0 and 40.0.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 3B
- Group 2: Cohort 1
- Group 3: Cohort 2B
- Group 4: Cohort 2A
- Group 5: Cohort 3A
Awards:
This trial has 0 awards, including: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.
Are patients exposed to any adverse effects when taking Mirabegron?
"The safety profile of Mirabegron is assessed to be a 1 due to the limited data from Phase 1 trials, which provides minimal evidence for both efficacy and security."
Answered by AI
Is there an eligibility criteria for participation in this clinical trial?
"This scientific trial is seeking 100 individuals between 18-40 years old with sclerocystic ovaries, BMI ranging from 20.0 to 45.0 kg/m2 and either diagnosed or suspected PCOS. Furthermore, it should be noted that participants must have a HOMA-IR higher than 5.9 or lower than 2.8 accompanied by HDL below 51 mg/dL or Fasting Insulin above 10.6 microU/mL; women included will need to utilize birth control such as hormonal intrauterine devices (IUDs), implants, oral contraceptives for the past three months excluding barrier methods exclusively - all ethnic"
Answered by AI
Are the opportunities to join this research still available?
"Affirmative. According to clinicaltrials.gov, this medical trial is actively recruiting individuals who meet the criteria for inclusion in the study. The trial was first posted on March 13th 2017 and has been revised most recently on November 16th 2022. Currently, 100 participants are being sought out across a single participating site."
Answered by AI
Is the age limit for enrollment in this trial greater than eighty-five years?
"As per the terms of this clinical trial, only individuals between 18 and 40 years old can be enrolled."
Answered by AI
What is the total enrolment capacity of this trial?
"Affirmative. The clinical trial listing on clinicaltrials.gov reveals that the study, initially announced in March 2017, is still actively enrolling participants. 100 volunteers are needed and one site will be hosting them all."
Answered by AI
In what other research projects has Mirabegron been featured?
"At the time of writing, there are 11 ongoing studies into Mirabegron with 2 Phase 3 trials. Among these 58 different sites conducting research, two locations have been designated in Marseille and Seoul Teugbyeolsi respectively."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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