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New treatment option for Diabetes
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 clairance study?
Renal clairance study is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diabetes.
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
- Diabetes mellitus is a non-transmissible disease whose incidence is growing worldwide . This pathology is defined by a chronic hyperglycaemia linked to a deficiency of either insulin secretion or its action or both.
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
- For all participant :
- No history of respiratory diseases
- Affiliated person or beneficiary of the French social security scheme.
- signed informed consent Group 1 ( For healthy volunteers):
- [18; 40] years old
You likely can't join if
- For all participants:
- 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
See the full eligibility criteria
- For all participant :
- No history of respiratory diseases
- Affiliated person or beneficiary of the French social security scheme.
- signed informed consent Group 1 ( For healthy volunteers):
- [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
- Normal to midly increased albuminuria: defined as ACR \< 3 mg/mmol For all the patients with T2D (group 2 and 3):
- 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
- No proliferative diabetic retinopathy Group 2 - For patients with T2D and no DKD:
- eGFR \> 60ml/min/1.73m2 and
- Normal to midly increased albuminuria: defined as ACR \< 3 mg/mmol Group 3 - For patients with DKD:
- eGFR [45-60 ml/min/1.73m2] and/or
- Moderately to severely increased ACR ≥ 3 mg/mmol
- For all participants:
- 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's taking place
- 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 - 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?
Study sites include Poitiers, France. 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.