BridgeMD
New treatment option for Postural Orthostatic Tachycardia Syndrome (POTS)
Official title POTS-FLOW: Interplay Between Gut Hormones and Autonomic Postprandial Blood Flow Regulation in Patients With POTS
ClinicalTrials.gov ID: NCT07019519
What this study is testing
- What it's testing
- This study will describe the interplay between the gut hormones GIP and CCK and their regulation of blood flow to the large vessels in patients with Postural Orthostatic Tachycardia Syndrome (POTS) and GIP, CCK and GLP-1 in healthy. This is addressed by hormone infusions during MR-scans of the abdomen and intake of oral glucose.
- You might receive a placebo (an inactive treatment) instead of the study drug, 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 to 50. Healthy volunteers may be eligible.
You may be able to join if
- POTS patients:
- Previously diagnosed with POTS in tilt test or active stand-test (either newly diagnosed within last 3 months or in new tilt test/active stand test...
- Reproducible orthostatic intolerance with raise in HR on \>30 bpm when standing within 10 minutes of change of supine to standing in age \>19 years...
- POTS symptoms/orthostatic intolerance
- Age 18-50
You likely can't join if
- Chronic illness
- Metallic implants
- Above 10 alcoholic drinks or week or substance abuse
- Other types of sinus tachycardia or heart disease
- Liverenzymes two times above normal values
- Decreased kidney function eGFR \<90 or elevated kreatinkinasis
See the full eligibility criteria
- POTS patients:
- Previously diagnosed with POTS in tilt test or active stand-test (either newly diagnosed within last 3 months or in new tilt test/active stand test during screenings visit)
- Reproducible orthostatic intolerance with raise in HR on \>30 bpm when standing within 10 minutes of change of supine to standing in age \>19 years or \>40 bpm in age 18-19 years.
- POTS symptoms/orthostatic intolerance
- Age 18-50
- Waist ratio \<180 cm
- Chronic illness
- Metallic implants
- Above 10 alcoholic drinks or week or substance abuse
- Other types of sinus tachycardia or heart disease
- Liverenzymes two times above normal values
- Decreased kidney function eGFR \<90 or elevated kreatinkinasis
- Thyroid disease or TSH out of reference
- Uncontrollable low or high blood pressure
- Blood vessels that cannot be visualized on MR
- Any disease that might influence the health of the participant during the study or participants that receives medicine that cannot be paused for 36 hours Inclusion Criteria:
- Age 18-50
- Waist ratio \<180 cm
- Matched a POTS patient in age, sex and BMI Exclusion Criteria:
- Chronic illness
- Metallic implants
- Above 10 alcoholic drinks or week or substance abuse
- POTS; other types of sinus tachycardia or heart disease
- Liverenzymes two times above normal values
- Decreased kidney function eGFR \<90 or elevated kreatinkinasis
- Thyroid disease or TSH out of reference
- Uncontrollable low or high blood pressure, Orthostatic hypotension
- Blood vessels that cannot be visualized on MR
- Any disease that might influence the health of the participant during the study or participants that receives medicine that cannot be paused for 36 hours
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
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 to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark. 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.