Philadelphia, PANCT06852365Now EnrollingIRB Ready

Metabolic Syndrome Clinical Trial in Philadelphia, PA

Access cutting-edge metabolic syndrome treatment through this phase 2 clinical trial at a research site in Philadelphia. Study-provided care at no cost to qualified participants.

Sponsored by University of Pennsylvania

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Expert Care in Philadelphia

Access metabolic syndrome specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related metabolic syndrome treatment provided free

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Check if you qualify for this metabolic syndrome clinical trial in Philadelphia, PA

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Why Participate?

  • No-Cost Study Care

  • Local to Philadelphia

    Convenient for PA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Philadelphia site if eligible
  4. 4Begin participation

About This Metabolic Syndrome Study in Philadelphia

This study will enroll women with PCOS to study the effects of first line therapy, oral contraceptive pills, and then either 12 weeks of resistant starch or 12 weeks of placebo to explore if resistant starch improves cardiometabolic parameters or impacts gut dysbiosis compared to placebo.

Sponsor: University of Pennsylvania

Who Can Participate

Inclusion Criteria

Women between ages of 18-40 years with BMI greater than or equal to 25 kg/m² to less than or equal to 48 kg/m² diagnosed with PCOS defined by the Rotterdam criteria based on a history of chronic anovulation (8 or fewer periods), androgen excess \[defined as total serum testosterone, free testosterone or a FAI greater than or equal to 90% of the upper limit of normal) or hirsutism (Ferriman-Gallwey score greater than 6 for Hispanics/ Black and greater than or equal to 2 for women of Asian descent)\] and polycystic ovaries as defined by a pelvic ultrasound (20 or more follicles or ovarian vol greater than 10cm3) or elevated AMH.
For women with more regular bleeding patterns, but who are suspected to be experiencing periodic anovulatory bleeding, a midluteal progesterone (P4) level less than 3ng/dL will be evidence of ovulatory dysfunction and qualify as anovulation.
Women with only hyperandrogenic PCOS phenotype (hyperandrogenism + one more criteria) will be included to decrease the heterogeneity of the cohort and as metabolic risks are increased in these women compared to normo-androgenic women with PCOS.
Subjects should be willing to avoid pregnancy for the entire duration of the study.

Exclusion Criteria

Subjects with other causes for irregular menses such as pregnancy, lactation, untreated hypothyroidism, untreated hyperprolactinemia and premature menopause.
Subjects with late onset adrenal hyperplasia
Subjects with history of bariatric surgery
Those who are unable to comply with the study procedures, for instance due to mental illness, substance abuse, or participation in other studies.
Subjects taking medications that affect weight or metabolic parameters (e.g. lipid lowering medications).
History of Crohn's disease and ulcerative colitis as well as current use of probiotics and laxatives are excluded.
Subjects could not have taken antibiotics for at least 3 months prior to randomization visit.
Subjects with greater than 20 g/day of dietary fiber intake based on pre-screening ASA-24 survey will be excluded.
Subjects with medical conditions that are contraindications to use of OCP and other medical conditions such as:
Type 1 or 2 diabetes
liver disease or dysfunctional liver (AST/ALT greater than 2x normal or a total bilirubin greater than 2.5 mg/dL)
renal disease (BUN greater than 30 mg/dL or serum creatinine greater than 1.4 mg/dL)
severe anemia (hemoglobin less than 10 mg/dL)
alcohol abuse
poorly controlled hypertension
TG greater than 250 mg/dl
chronic inflammatory conditions such as psoriasis
history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; known heart disease (New York Heart Association Class II or higher)
history of cervical carcinoma, endometrial carcinoma, or breast carcinoma, adrenal or ovarian tumor secreting androgens, and Cushing's syndrome -

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Philadelphia?

Yes, this clinical trial (NCT06852365) has an active research site in Philadelphia, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Metabolic Syndrome Treatment Options in Philadelphia, PA

If you're searching for metabolic syndrome treatment options in Philadelphia, PA, this clinical trial (NCT06852365) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Philadelphia research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced metabolic syndrome specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all metabolic syndrome clinical trials near you to find additional studies recruiting in your area.

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