Diabetes study: Renal clairance study
Official title Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease
ClinicalTrials.gov ID: NCT06846034
What this study is testing
What is Renal clearance study?
An investigational diagnostic procedure being studied to assess kidney function in people with diabetes. It is designed to measure glomerular filtration rate (GFR) and effective renal plasma flow (ERPF) by infusing aminoph Hippurate (PAH) and iohexol and analyzing their clearance.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether a brief drop in oxygen levels alters kidney blood‑flow measurements, and if this could help detect early kidney problems.
- Who it's for
- Adults who are healthy, have type 2 diabetes, or have diabetes with kidney disease.
- What's involved
- Participants will breathe a low‑oxygen gas for a short time while doctors use imaging to measure kidney blood flow; the procedure involves a few clinic visits and non‑invasive tests.
- Time commitment
- The study takes a few hours over one or two visits to complete the breathing test and measurements.
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 75. Healthy volunteers may be eligible.
You may be able to join if
- No history of respiratory diseases
- Affiliated person or beneficiary of the French social security scheme.
- [18; 40] years old
- No history of diabetes
- No acute/long term \> 3 months drug use except contraception
You likely can't join if
- Active smoking
- Contraindication to any of the agent (PAH, or iohexol or gadolinium) used in the study.
- Contraindication to cardiac MRI, renal MRI, respiratory tests,
- History acute coronary syndrome or coronary revascularization
- Recent (\<6 months) history of: Heart failure requiring hospitalisation or Stroke or transient ischemic neurologic disorder
- Severe unstable hypertension (≥180 mmHg systolic or ≥110 mmHg diastolic blood pressure)
See the full eligibility criteria
- No history of respiratory diseases
- Affiliated person or beneficiary of the French social security scheme.
- [18; 40] years old
- No history of diabetes
- No acute/long term \> 3 months drug use except contraception
- BMI: [18,5 - 29,9]kg/m2
- eGFR \> 60ml/min/1.73m2
- Diagnosed T2D according to ADA criteria
- [35; 75] years old
- Stable treatment of diabetes and/or antihypertension for at least 2 months prior to inclusion
- eGFR \> 60ml/min/1.73m2 and
- eGFR [45-60 ml/min/1.73m2] and/or
- Moderately to severely increased ACR ≥ 3 mg/mmol
- Active smoking
- Contraindication to any of the agent (PAH, or iohexol or gadolinium) used in the study.
- Contraindication to cardiac MRI, renal MRI, respiratory tests,
- History acute coronary syndrome or coronary revascularization
- Recent (\<6 months) history of: Heart failure requiring hospitalisation or Stroke or transient ischemic neurologic disorder
- Severe unstable hypertension (≥180 mmHg systolic or ≥110 mmHg diastolic blood pressure)
- Resting oxygen saturation \<95% at baseline
- Any concomitant disease or condition that may interfere with the safety or the possibility for the patient to comply with or complete the study protocol.
- History of severe mountain sickness (dizziness, headache, nausea/vomiting and incapaciting fatigue)
- Consumption of SGLT2 inhibitors
- Concurrent participation in another clinical research study
- Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception
- Persons benefiting from enhanced protection under french national law
- Persons under psychiatric care who are unable to give their consent
The study team makes the final eligibility decision.
Where it is enrolling
- Poitiers, France
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, but 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 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Poitiers, France. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.