Trial Outcomes & Findings for Examining Genetic Influence on Response to Beta-Blocker Medications in People With Type 2 Diabetes (NCT NCT00925119)

NCT ID: NCT00925119

Last Updated: 2019-09-26

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

31 participants

Primary outcome timeframe

8 weeks

Results posted on

2019-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	Atenolol Participants will receive atenolol for 8 weeks. Atenolol: 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
Overall Study STARTED	31
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Examining Genetic Influence on Response to Beta-Blocker Medications in People With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atenolol n=19 Participants Participants will receive atenolol for 8 weeks. Atenolol: 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
Age, Continuous	57 years STANDARD_DEVIATION 11 • n=99 Participants
Sex: Female, Male Female	11 Participants n=99 Participants
Sex: Female, Male Male	8 Participants n=99 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Data were not able to be collected from the echocardiography.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline and Week 8

Population: Modeling data not available in all subjects

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.

Outcome measures

Outcome measures
Measure	Atenolol n=5 Participants Participants will receive atenolol for 8 weeks. Atenolol: 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
Change in Free Fatty Acid Kinetics	2.02 mU/mL Standard Deviation 16.5

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Data available in 17 subjects

(Post atenolol triglycerides - Pre atenolol triglycerides)

Outcome measures

Outcome measures
Measure	Atenolol n=17 Participants Participants will receive atenolol for 8 weeks. Atenolol: 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
Change in Triglycerides	17 mg/dL Standard Deviation 65

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Post and Pre atenolol data available in 17 subjects

As measured by the Homeostatic model assessment of insulin resistance (HOMA2-IR) (post atenolol - pre atenolol). he Homeostatic model assessment (HOMA) is a method for assessing insulin sensitivity from fasting glucose and insulin. A higher HOMA value indicates higher insulin resistance. The widely-used formulae available for HOMA1 provide only linear approximations of HOMA\_%B and HOMA\_IR, the inverse of HOMA\_%S. These are: HOMA1\_IR = \[FPI (uU/ml) x FPG (mmol/l) \]/22.5 HOMA1\_%B = (20 x FPI)/(FPG - 3.5) The results obtained for HOMA2 may differ considerably from HOMA1 computer-calculated values, especially for more extreme glucose and insulin values. For this reason, no attempt has been made to provide linear approximations of HOMA2 calculated values of HOMA\_%B, HOMA\_IR and HOMA\_%S. The software needed to calculate HOMA2 values is available on this website: https://www.dtu.ox.ac.uk/homacalculator/download.php, subject to the conditions specified on the downloads page.

Outcome measures

Outcome measures
Measure	Atenolol n=17 Participants Participants will receive atenolol for 8 weeks. Atenolol: 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
Change in Insulin Sensitivity	-0.05 arbitrary units Standard Deviation 0.84

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Data could not be determined because assumptions for MINMOD model were not met.

Glucose effectiveness as measured by insulin-modified IV glucose tolerance test using the MINMOD model.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 8

Outcome measures

Outcome measures
Measure	Atenolol n=19 Participants Participants will receive atenolol for 8 weeks. Atenolol: 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
Change in HDL	-3.5 mg/dL Standard Deviation 5.8

SECONDARY outcome

Timeframe: Baseline and Week 8

fasting insulin (post - pre atenolol)

Outcome measures

Outcome measures
Measure	Atenolol n=17 Participants Participants will receive atenolol for 8 weeks. Atenolol: 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
Change in Insulin	-0.55 mU/mL Standard Deviation 6.03

Adverse Events

Atenolol

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Atenolol n=19 participants at risk Participants will receive atenolol for 8 weeks. Atenolol: 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
General disorders Fatigue	10.5% 2/19
Cardiac disorders Bradycardia	21.1% 4/19

Additional Information

Dr. Amber Beitelshees

University of Maryland

Phone: 410-706-0118

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place