Chronic Kidney Disease, T2DM
Conditions
Interventions
Three arms:
1. Oral + placebo:
- Oral: 154 mmol sodiumchloride (9 gram) diluted in 254 cc water
-Intervenous: glucose 5% diluted in 46 mL 0.9% isotonic saline
2. Oral + GLP-1
- Oral: 1
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: Group 1: T2DM patients with DKD • Male between 40 and 75 years old • Caucasian • Average daily sodium intake of 150 mmol/day • Known with Diabetes Mellitus - type 2, according to the ADA criteria • One of the following criteria: o Microalbuminuria defined as either albuminuria >20 mg/L in a morning urine sample or albuminuria >30 mg/24 hrs collected in a 24-hours urine collection or albumin-to-creatinine ratio >3 mg/mmol in a morning urine sample o Creatinine clearance 75 ml/min and 75 ml/min, without microalbuminuria • Non-treated office blood pressure = 140/90 mmHg • Normal glucose tolerance as assessed by a 75-g oral glucose tolerance test (OGTT) according to ADA criteria • Capable of giving written informed consent and able to comply with the requirements and restrictions listed in the informed consent form
Exclusion criteria
Exclusion criteria: A potential subject of any of the three groups who meets one or more of the following criteria will be excluded from participation in this study: • An office blood pressure >160/90 mmHg • A major illness in the past 3 months or any significant chronic medical illness that the Investigator would deem unfavourable for enrolment, including chronic inflammatory diseases • Current use of the following medication: thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, oral glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics, antipsychotics, tricyclic antidepressants, diuretics and monoamine oxidase inhibitors • A history of any type of malignancy within the past 5 years with the exception of successfully treated basal cell cancer of the skin • A history of cardiovascular disease (in the past 6 months) defined as documented coronary artery disease including myocardial infarction, (un-)stable angina pectoris or acute coronary syndrome, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, cerebrovascular disease including ischemic and hemorrhagic stroke or a subarachnodial bleeding, or peripheral artery disease including aortic aneurysmata • A history of coagulation disorders • A history, within 3 years, of drug abuse (including benzodiazepines, opioids, amphetamine, cocaine, THC, methamphetamine) • A history of alcoholism and/or is drinking more than 3 units of alcohol per day. Alcoholism is defined as an average weekly intake of >21 units for males. One unit is equivalent to 8 g of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits • Difficulty in donating blood or limited accessibility of a vein in left and right arm • Subject has donated blood in last 3 months • Use of tobacco products • Any other issue that, in the opinion of the Investigator, could be harmful to the subject or compromise interpretation of the data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the timed effects of a matched acute oral sodium load (in the absence or presence of GLP-1 receptor agonist) or an acute intravenous sodium load in healthy individuals and T2DM patients with/without renal impairment on urinary sodium excretion after 24h, determined by the cumulative sodium balance. | — |
Secondary
| Measure | Time frame |
|---|---|
| The most important secondary efficacy parameters include the effect of an acute oral versus intravenous sodium load on: • Variation in blood pressure, determined by a non-invasive, automated, beat-to-beat blood pressure monitor (Nexfin®) measurements and 24h ABPM device • Differences in total and fractional urinary sodium excretion after 2,4 and 6 hours • Differences in plasma, urine and systemic hemodynamic markers | — |
Contacts
Public ContactLot Mosterd
Department of Internal Medicine, Amsterdam University Medical Centre, location VUMC
Outcome results
None listed