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New treatment option for Cardiovascular Kidney Metabolic Syndrome
Official title Food and Fitness With Medicine (FFWM)
ClinicalTrials.gov ID: NCT07027995
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Diagnosis of at least one of the following conditions: hypertension, type 2 diabetes, hyperlipidemia, chronic kidney disease, and/or metabolic...
- 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.
You likely can't join if
- Conditions that impact digestion, metabolism, or food intake (e.g. surgical loss of esophagus, stomach, or colon, pancreatic dysfunction, bariatric...
- Participants with uncontrolled mental illness disorders (e.g., schizophrenia, bipolar disorder, major depression, etc.) that are not well-managed or...
- 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
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
- Upper Arlington, Ohio, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States; Upper Arlington, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.