NCT02046395

Brief Summary

The purpose of this study is to study the effect of blocking the renin angiotensin system on urinary free light chain excretion as compared to urine microalbumin creatinine ratio in subjects with type 2 diabetes. The long term goal is to assess urinary free-light chains as a biomarker of earlier detection of kidney function impairment in subjects with diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4 type-2-diabetes

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

August 21, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

7.9 years

First QC Date

January 23, 2014

Results QC Date

March 31, 2022

Last Update Submit

August 17, 2023

Conditions

Type 2 DiabetesHypertension

Keywords

Type 2 DiabetesHypertension

Outcome Measures

Primary Outcomes (1)

  • Change in Urine Microalbumin Creatinine Ratio

    Kidney function will be assessed throughout the study to assess changes in function prior to the washout of ACE/ARB medication and reintroduction of the ACE/ARB medication.

    Visit 1 (Baseline), Visit 3 (Day 60)

Secondary Outcomes (1)

  • Change in the Level of Urinary Free Light Chains

    Visit 1 (Baseline), Visit 3 (Day 60)

Study Arms (1)

Washout Period for 30 days

OTHER

In the washout period, the Ace Inh or ARB classes of medicine(s) that are part of the patient's antihypertensive regimen will be discontinued. The patient will be started on alternative therapy with medications that are approved by the Food and Drug Administration for treatment of high blood pressure (such as amlodipine, hydralazine, terazosin or Hydrochlorothiazide) for control of their blood pressure. The goal for their blood pressure will be set at \< 140/90 mm/Hg. The washout period will last for four weeks at the end of which the patient will enter the test period.

Drug: amlodipine, hydralazine, terazosin or hydrochlorothiazide

Interventions

amlodipine, hydralazine, terazosin or hydrochlorothiazideDRUG

In the washout period, the Ace Inh or ARB classes of medicine(s) that are part of the patient's antihypertensive regimen will be discontinued. The patient will be started on alternative therapy with medications that are approved by the Food and Drug Administration for treatment of high blood pressure (such as amlodipine, hydralazine, terazosin or Hydrochlorothiazide) for control of their blood pressure.

Also known as: Norvasc
Washout Period for 30 days

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes
  • Hypertension
  • Estimated glomerular filtration rate (eGFR) \> 30 ml/min
  • Use of Ace Inh and ARB for control of blood pressure who are willing to be placed on alternate drug(s) in the washout period for blood pressure control

You may not qualify if:

  • Pregnancy
  • Patients with chronic kidney disease stage with eGFR \< 30 ml/min (CKD stage IV and V)
  • Nephrotic range proteinuria (urinary protein \> 3.5 gm/day)
  • History or renal transplantation
  • History of multiple myeloma
  • Known history of hypersensitivity reaction or intolerability to Ace Inh or ARB.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hypertension

Interventions

AmlodipineHydralazineTerazosinHydrochlorothiazide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhthalazinesPyridazinesChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Vechi Batuman
Organization
Tulane University
vbatuma@tulane.edu
(504)988-5346

Study Officials

  • Vechi Batuman, MD

    Tulane University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2014

First Posted

January 27, 2014

Study Start

January 1, 2012

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

August 21, 2023

Results First Posted

August 21, 2023

Record last verified: 2023-08

Locations

US(1)