Phase 4
Completed N=34
PROTOCOL 3: Role of the Renal Nerves in the Increase in EGP in Response to Glucosuria
Source: ClinicalTrials.gov NCT03168295 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Change in Endogenous Glucose Production (EGP) — 2.03; 1.92; 1.55; 1.68 mg/kg.min
◆ Published Evidence
Established
33citations · ~6 / year
Increase in endogenous glucose production with SGLT2 inhibition is attenuated in individuals who underwent kidney transplantation and bilateral native nephrectomy.
Summary
Purpose/Objectives: Examining the effect of SGLT2 inhibition on EGP and plasma glucose concentration in diabetic and non-diabetic subjects after kidney transplantation (i.e. renal denervation) or in subjects after renal sympathectomy (63) can add insight about the possible role of a neural arc which mediates the changes in plasma glucagon and/or insulin concentration in response to glucosuria.
Linked Publications (2)
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Increase in endogenous glucose production with SGLT2 inhibition is attenuated in individuals who underwent kidney transplantation and bilateral native nephrectomy.
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Increase in Endogenous Glucose Production With SGLT2 Inhibition Is Unchanged by Renal Denervation and Correlates Strongly With the Increase in Urinary Glucose Excretion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Endogenous Glucose Production (EGP) |
2.03; 1.92; 1.55; 1.68; 2.21; 1.85 | — |
| SECONDARY Change in Fasting Plasma Glucose |
143; 124; 143; 135.7; 112; 106.6 | — |
| SECONDARY Change in Fasting Plasma Insulin |
12; 10; 14; 15.2; 11; 9.9 | — |
Eligibility Criteria
Inclusion Criteria
- age = 18-70 years
- BMI = 18.5-40 kg/m2
- HbA1c ≥ 7.0% and ≤10.0% for type 2 diabetics
- males or females
- Must be at least 3 months post renal transplantation and be on a stable dose of prednisone (≤5 mg/day), tacrolimus, and mycophenolate mofetil
- Not taking any antidiabetic medications or who are treated with metformin, sulfonylurea, dipeptidyl peptidase 4 (DPP4) inhibitor, thiazolidinedione or some combination
- Must be in good general health as determined by physical exam, medical history, blood chemistries, CBC, TSH, T4, EKG and urinanalysis
Exclusion Criteria
- Subjects who are taking insulin or SGLT2 inhibitor are excluded
- Only subjects whose body weight has not been stable (± 3 lbs) over the preceding three months and/or who participate in an excessively heavy exercise program will be excluded.
- Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine >1.4 females or >1.5 males (and eGFR 300 mg will be excluded.
Data sourced from ClinicalTrials.gov (NCT03168295) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.