BridgeMD
New treatment option for Type2diabetes
Official title Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF)
ClinicalTrials.gov ID: NCT06337812
What this study is testing
- What it's testing
- The study team is studying how increasing dietary fiber, specifically through adding potato starch to participant's diet, may impact the species of bacteria in participant's gut microbiome. The study team also wants to understand if adding potato starch to participant's diet helps these bacteria make more short chain fatty acids, a byproduct the team thinks may benefit participant's health.
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
You may be able to join if
- A confirmed clinical diagnosis of stable HFpEF on maximally tolerated Heart Failure (HF) medical regimen (without changes in dosage in the prior...
- Left ventricular ejection fraction of \>50% documented in the prior 12 months
- A confirmed clinical diagnosis of Type II diabetes (T2DM) with glycated hemoglobin \<10% without changes in medical regimen in the past month.
You likely can't join if
- Current usage of pre- or probiotic usage
- Antibiotic usage in the past 6 months
- Current participation in another treatment clinical trial
- History of potato allergy or potato starch allergy, inflammatory bowel syndrome, inflammatory bowel disease, bowel resection, Roux-en-Y gastric...
- Hypoglycemic episode with blood glucose 70 milligrams per deciliter (mg/dL) within the last month
- Stage IV-V chronic kidney disease
See the full eligibility criteria
- A confirmed clinical diagnosis of stable HFpEF on maximally tolerated Heart Failure (HF) medical regimen (without changes in dosage in the prior month)
- Left ventricular ejection fraction of \>50% documented in the prior 12 months
- A confirmed clinical diagnosis of Type II diabetes (T2DM) with glycated hemoglobin \<10% without changes in medical regimen in the past month.
- Current usage of pre- or probiotic usage
- Antibiotic usage in the past 6 months
- Current participation in another treatment clinical trial
- History of potato allergy or potato starch allergy, inflammatory bowel syndrome, inflammatory bowel disease, bowel resection, Roux-en-Y gastric bypass surgery, celiac disease, Crohn's disease, or colorectal cancer
- Hypoglycemic episode with blood glucose 70 milligrams per deciliter (mg/dL) within the last month
- Stage IV-V chronic kidney disease
- Pregnancy (self-reported)
- Comorbidity limiting survival to \< 12 months
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, 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.