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HomeTrials › NCT07027995

Type 2 diabetes · Not applicable · Recruiting now

Food and Fitness With Medicine (FFWM)

NCT07027995 · Sponsor: Ohio State University

What this trial means for you

This study is recruiting now at 4 US sites. It's studying see the official record for cardiovascular kidney metabolic syndrome, type 2 diabetes.

Who can joinWomen, 18 Years and older
Healthy volunteersNo — diagnosis required
What you'd takesee the official record
Study length~2.8 years overall
Planned participants200
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

Food and Fitness with Medicine (FFWM) is a 24-week randomized controlled trial (RCT) enrolling 200 post-menopausal women (PMW) with stage 2 cardio-kidney metabolic (CKM) syndrome and type-2 diabetes (T2D) within 6 weeks of initiating glucagon-like peptide-1 receptor agonist (GLP-1RAs) to: 1. Examine discontinuation rates of GLP-1RAs (primary outcome); 2. Compare change in American Heart Association (AHA) PREVENT scores (secondary outcome); and 3. Examine the effects of FFWM on biologic mechanisms responsive to weight loss and cardiovascular health (CVH) including dermal carotenoids, body composition and metabolite biomarkers.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

Inclusion Criteria: * Diagnosis of at least one of the following conditions: hypertension, type 2 diabetes, hyperlipidemia, chronic kidney disease, and/or metabolic syndrome. * At least 18 years of age at the time of signing consent. * Participants must have reliable transportation to attend Exercise is Medicine sessions. * Access to an internet-enabled device. * No objections to online grocery shopping, home food deliveries, or nutrition counseling. * Residence meets Instacart delivery requirements (e.g., non-institutionalized). * Participant is willing to use a personal credit card for Instacart back-up payments. * Participants must speak English to be able to consent and engage in FIM and EIM programs. * Participant has been clinically prescribed GLP-1RA's. Exclusion Criteria: * Conditions that impact digestion, metabolism, or food intake (e.g. surgical loss of esophagus, stomach, or colon, pancreatic dysfunction, bariatric surgery, brain surgery that alters cognition, etc.). * Participants with uncontrolled mental illness disorders (e.g., schizophrenia, bipolar disorder, major depression, etc.) that are not well-managed or controlled through treatment, as determined by the study team. * Familial history of certain cancers (e.g., multiple endocrine neoplasia, medullary thyroid carcinoma, etc.). * Active digestive illnesses (i.e., Celiac disease, irritable bowel syndrome, chronic malabsorption). * Comorbidities such as psychiatric or general illness that may put the subject at risk as determined by the investigator/s. * Renal impairment, eGFR \< 60 ml/min/1.73m2 * Factor which, in the investigator's opinion, is likely to compromise the subject's ability to participate in the study. * Recent participation (e.g., 3 months) in other behavioral nutrition trials or programs (i.e., bariatric programs, diabetes education programs). * Currently pregnant or planning to become pregnant during the study. * Participant is not willing to provide a urine, blood, or stool sample.

Study sites by state

Ohio

  • Ohio State Healthy Community Center — Columbus · Active, not recruiting
  • Ohio State East Hospital — Columbus · Opening soon
  • Martha Morehouse — Columbus · Recruiting now
  • Ohio State Outpatient Care Upper Arlington — Upper Arlington · Active, not recruiting

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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