Trial Outcomes & Findings for Study of Cholesterol Levels and Types in African Americans With Type 2 Diabetes (NCT NCT01494298)

NCT ID: NCT01494298

Last Updated: 2013-12-13

Results Overview

Apolipoprotein B Age adjusted least square means are reported because of baseline differences in ages.

Recruitment status

COMPLETED

Target enrollment

111 participants

Primary outcome timeframe

At study entry

Results posted on

2013-12-13

Participant Flow

Inclusion criteria were male gender, African American by self report and not taking of lipid-lowering medications. Subjects with diabetes were recruited from the Grady Diabetes Clinic in Atlanta, Georgia. Control subjects were recruited from the general Metro-Atlanta Area and had to have a fasting blood glucose \<100 mg/dL.

1 subject was excluded from the diabetes group because he had type 1 diabetes Exclusion from control group 1- was taking lipid lowering medications 1 - was not possible to do venous blood draw 5 - FBG between 100-126 mg/dL 2 - FBG\>126 and were reassigned to diabetes group

Participant milestones

Participant milestones
Measure	T2DM African American men with type 2 diabetes and not taking cholesterol-lowering medications.	Controls African American men without type 2 diabetes and not taking cholesterol-lowering medications.
Overall Study STARTED	56	55
Overall Study COMPLETED	54	47
Overall Study NOT COMPLETED	2	8

Reasons for withdrawal

Reasons for withdrawal
Measure	T2DM African American men with type 2 diabetes and not taking cholesterol-lowering medications.	Controls African American men without type 2 diabetes and not taking cholesterol-lowering medications.
Overall Study Protocol Violation	2	8

Baseline Characteristics

Study of Cholesterol Levels and Types in African Americans With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	T2DM n=54 Participants African American Men with Type 2 Diabetes	Controls n=47 Participants African American Men without diabetes	Total n=101 Participants Total of all reporting groups
Age Continuous	52 Years STANDARD_DEVIATION 8 • n=5 Participants	44.5 Years STANDARD_DEVIATION 13.1 • n=7 Participants	48.5 Years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	47 Participants n=7 Participants	101 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	54 Participants n=5 Participants	47 Participants n=7 Participants	101 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	54 participants n=5 Participants	47 participants n=7 Participants	101 participants n=5 Participants

PRIMARY outcome

Timeframe: At study entry

Apolipoprotein B Age adjusted least square means are reported because of baseline differences in ages.

Outcome measures

Outcome measures
Measure	T2DM n=54 Participants	Controls n=47 Participants
ApoB Levels in African American Men With Diabetes and Those Without.	80 mg/dL Standard Error 3	65 mg/dL Standard Error 3

SECONDARY outcome

Timeframe: at entry

LDL size subclassification was divided into the following groups (from largest size to smallest size): LDL I, LDL IIa, LDL IIb, LDL IIIa, LDL IIIb, LDL IVa, LDL IVa, and LDL IVb. For differences posted P\<0.05 for LDL I, LDL IIb, LDL IIIa, and LDL IIIa +b

Outcome measures

Outcome measures
Measure	T2DM n=54 Participants	Controls n=47 Participants
LDL Density in African American Males With Diabetes and Those Without Diabetes LDL I	21 percentage of total LDL particles Standard Error 1	29 percentage of total LDL particles Standard Error 1
LDL Density in African American Males With Diabetes and Those Without Diabetes LDL IIa	24 percentage of total LDL particles Standard Error 1	27 percentage of total LDL particles Standard Error 1
LDL Density in African American Males With Diabetes and Those Without Diabetes LDL IIb	29 percentage of total LDL particles Standard Error 1	24 percentage of total LDL particles Standard Error 1
LDL Density in African American Males With Diabetes and Those Without Diabetes LDL IIIa	18 percentage of total LDL particles Standard Error 1	13 percentage of total LDL particles Standard Error 1
LDL Density in African American Males With Diabetes and Those Without Diabetes LDL IIIb	3.3 percentage of total LDL particles Standard Error 0.3	3.4 percentage of total LDL particles Standard Error 0.3
LDL Density in African American Males With Diabetes and Those Without Diabetes LDL IVa	2.8 percentage of total LDL particles Standard Error 0.2	2.8 percentage of total LDL particles Standard Error 0.2
LDL Density in African American Males With Diabetes and Those Without Diabetes LDL IVb	1.4 percentage of total LDL particles Standard Error 0.1	1.3 percentage of total LDL particles Standard Error 0.1
LDL Density in African American Males With Diabetes and Those Without Diabetes LDL IIIa +b	21 percentage of total LDL particles Standard Error 2	16 percentage of total LDL particles Standard Error 2

SECONDARY outcome

Timeframe: at study entry

Outcome measures

Outcome measures
Measure	T2DM n=54 Participants	Controls n=47 Participants
Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without.	43 mg/dL Standard Error 5	45 mg/dL Standard Error 5

Adverse Events

T2DM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gina Ryan Clinical Professor

Mercer University College of Pharmacy

Phone: 678.547.6222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60