Effects of Empagliflozin on Endogenous Glucose Production in End Stage Renal Disease(ESRD).

University of Pisa

Status and phase: Completed; Phase 2

Conditions: End Stage Renal Disease

Treatments: Drug: Placebo; Combination Product: Empagliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT03713190

EMPA-1

Details and patient eligibility

About

A study of the effects of empagliflozin, a SGLT-2 inhibitor, on endogenous glucose production and plasma glucagon levels in patients with end-stage renal disease (ESRD)

Full description

The impact of SGLT-2 inhibition on endogenous glucose production and plasma glucagon levels will be compared measured in patients with ESRD.The secondary endpoints are the mean difference in plasma glucose, insulin, c-peptide, FFA,GH, epinephrine, norepinephrine, cortisol and blood pressure during the last hour of the experiment between empagliflozin versus placebo administration in patients.

Enrollment: 25 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Males and females
2. Age = 30-70 years
3. BMI< 40 Kg/m 2 and stable weight (± 3 lbs) over the preceding three months
4. Normal Glucose Tolerance (HbA1c > 4.5 % and < 5.7%) or Type 2 diabetes (HbA1c >5.7 % and <10.0%)
5. End Stage Renal Disease (GFR <15 ml/min/1.73 m 2 or hemodialysis)
6. Subjects are capable of giving informed consent

Exclusion criteria

1. Prednisone treatment
2. Beta blocker or any medication that affects sympathetic/parasympathetic activity
3. Known Empagliflozin Excipient Hypersensitivity
4. Liver function enzymes higher more than two times the upper limit
5. Ongoing urinary tract infection
6. history of cancer of any type;
7. cerebrovascular or symptomatic peripheral vascular disease;
8. heart disease class III or IV NYHA;
9. Type 1 Diabetes
10. drug or alcohol abuse;
11. life expectancy <3 yrs
12. blood pressure >150/100 mmHg
13. Donation of blood to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of > 400 mL of blood during the 8 weeks prior to the enrollment visit and at least 8 weeks thereafter
14. Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment)
15. Patient with a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose an unacceptable risk to the patient or interfere with trial procedures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

Empagliflozin

Active Comparator group

Description:

SGLT-2 inhibitor

Treatment:

Combination Product: Empagliflozin

placebo

Placebo Comparator group

Description:

A substance without specific pharmacology principles.

Treatment:

Drug: Placebo

Combination Product: Empagliflozin