Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 74 of 88 for:    NIDDK endocrine and diabetes | Recruiting, Not yet recruiting, Available Studies

PROTOCOL 3: Role of the Renal Nerves in the Increase in EGP in Response to Glucosuria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03168295
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : June 1, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ralph DeFronzo, The University of Texas Health Science Center at San Antonio

Brief Summary:
Purpose/Objectives: Examining the effect of SGLT2 inhibition on EGP and plasma glucose concentration in 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Dapagliflozin 10mg Drug: Placebo Oral Tablet Phase 4

Detailed Description:

Purpose/Objectives: Examining the effect of SGLT2 inhibition on EGP and plasma glucose concentration in 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.

Research Design/Plan: After screening, eligible subjects will receive 2 measurements of endogenous glucose production with a prime-continuous infusion of 3-3H-glucose. Each measurement will be performed on a separate day in random order after a 10-12 hour overnight fast and will last 8 hours (from 6 AM to 2 PM). After a 3-hour tracer equilibration period, each subject will receive one of the following medications in random order: (i) placebo and (ii) dapagliflozin 10 mg. Following the test medication at 9 AM, blood samples will be drawn every 20 minutes for an additional 5 hours and plasma glucose, insulin, C-peptide, glucagon, catecholamine concentrations and tritiated glucose sp act will be measured.

Methods: Visit 1: Screening Visit 2: Endogenous Glucose Production Measurement (EGP) Visit 3: After completing the first EGP measurement, subjects will return to the Diabetes Research Unit for the second study.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Post renal transplant type 2 diabetes mellitus patients and type 2 diabetes mellitus patients without renal transplant
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: SGLT2 INHIBITION AND STIMULATIION OF ENDOGENOUS GLUCOSE PRODUCTION Significance - PROTOCOL 3: Role of the Renal Nerves in the Increase in EGP in Response to Glucosuria
Actual Study Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dapa arm
After a 3-hour tracer equilibration period, each subject will receive (ii) dapagliflozin 10 mg.
Drug: Dapagliflozin 10mg
SGLT2 inhibitor - Dapagliflozin
Other Name: Farxiga

Placebo Comparator: Placebo arm
After a 3-hour tracer equilibration period, each subject will receive (i) placebo
Drug: Placebo Oral Tablet
Placebo for Dapagliflozin
Other Name: Placebo




Primary Outcome Measures :
  1. Endogenous Glucose production Post Renal [ Time Frame: 8 hours ]
    Endogenous Glucose production in diabetics Post Renal transplant

  2. Endogenous Glucose production Non - Renal [ Time Frame: 8 hours ]
    Endogenous Glucose production in diabetics with no Renal transplant



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Post Renal T2DM subjects

  • age = 18-70 years
  • BMI = 18.5-40 kg/m2
  • HbA1c ≥ 7.0% and ≤10.0%.
  • 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, 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

No Renal Transplant

  • age = 18-70 years
  • BMI = 18.5-40 kg/m2
  • HbA1c ≥ 7.0% and≤ 10.0%.
  • males or females
  • On stable dose (more than 3 months) of monotherapy or combination therapy with metformin and/or a sulfonylurea
  • Must be in good general health as determined by physical exam, medical history, blood chemistries, CBC, TSH, T4, EKG and urinanalysis

Exclusion Criteria:

Post Renal T2DM subjects

  • 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 <45ml/min.1.73m2), or 24-hour urine albumin excretion > 300 mg will be excluded.

No Renal Transplant

  • Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea)
  • 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 <45 ml/min.1.73m2), or 24-hour urine albumin excretion > 300 mg will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03168295


Contacts
Layout table for location contacts
Contact: Ralph A DeFronzo, MD 2105676710 defronzo@uthscsa.edu
Contact: Monica Palomo, BS 2105676710 palomom@uthscsa.edu

Locations
Layout table for location information
United States, Texas
The University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Ralph A DeFronzo, MD    210-567-6691    defronzo@uthscsa.edu   
Principal Investigator: Ralph A DeFronzo, MD         
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Ralph A DeFronzo, MD The University of Texas Health Science at San Antonio

Layout table for additonal information
Responsible Party: Ralph DeFronzo, Professor of Medicine, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT03168295     History of Changes
Other Study ID Numbers: HSC20160042H
R01DK107680 ( U.S. NIH Grant/Contract )
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs