NCT00925119

Brief Summary

Beta-blockers are medications used to treat cardiovascular disease (CVD) symptoms, including high blood pressure and chest pain. People with diabetes who receive beta-blockers may experience adverse health effects, but the exact cause of why this happens remains unknown. This study will examine the genetic factors that may influence how atenolol, a beta-blocker medication, affects fat breakdown, blood sugar levels, and heart function in people with type 2 diabetes.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

December 22, 2017

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

3.5 years

First QC Date

June 17, 2009

Results QC Date

April 21, 2017

Last Update Submit

September 24, 2019

Conditions

Diabetes Mellitus, Type 2

Keywords

DiabetesAtenololGenetic

Outcome Measures

Primary Outcomes (2)

  • Change in Diastolic Function (Annular Tissue Velocity [Em])

    8 weeks

  • Change in Free Fatty Acid Kinetics

    Estimate of peripheral lipolysis using modeling of free fatty acid levels collected during an IV glucose tolerance test. The change in threshold for insulin action (post-atenolol minus pre-atenolol) is the primary variable from this modeling that we analyzed.

    Baseline and Week 8

Secondary Outcomes (5)

  • Change in Triglycerides

    Baseline and Week 8

  • Change in Insulin Sensitivity

    Baseline and Week 8

  • Change in Glucose Effectiveness

    Baseline and Week 8

  • Change in HDL

    Baseline and Week 8

  • Change in Insulin

    Baseline and Week 8

Study Arms (1)

Atenolol

EXPERIMENTAL

Participants will receive atenolol for 8 weeks.

Drug: Atenolol

Interventions

AtenololDRUG

12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated

Atenolol

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • Pre-Diabetes

You may not qualify if:

  • Insulin therapy
  • Treatment with any beta-blocker in the 30 days before study entry
  • Asthma
  • Chronic obstructive pulmonary disease (COPD)
  • Greater than first degree heart block
  • Heart rate less than 60 bpm
  • Systolic blood pressure less than 90 mm Hg
  • Raynaud's phenomenon
  • Known history of angina, heart attack, heart failure, coronary revascularization, or automatic implantable cardioverter defibrillators
  • Pregnant
  • Creatinine clearance less than 35 ml/min
  • Hematologic dysfunction (white blood cell \[WBC\] count less than 3000 or hematocrit less than 28%)
  • Allergy to amide anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Atenolol

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Results Point of Contact

Title
Dr. Amber Beitelshees
Organization
University of Maryland
abeitels@medicine.umaryland.edu
410-706-0118

Study Officials

  • Amber L. Beitelshees, PharmD, MPH

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2009

First Posted

June 19, 2009

Study Start

December 1, 2009

Primary Completion

June 1, 2013

Study Completion

May 1, 2014

Last Updated

September 26, 2019

Results First Posted

December 22, 2017

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)