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Scientific Article1
Scientific Article1
Division of Public Health Sciences, Department of Epidemiology and Prevention, Wake Forest University Health Sciences
b
Department of Internal Medicine, Wake Forest University Health Sciences
c
Departments of Medicine and Epidemiology, The Johns Hopkins University
d
Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases
e
University of Minnesota
f
University of Washington
g
University of Alabama at Birmingham
h
Departments of Internal Medicine and Epidemiology, University of Michigan
i
The University of Texas Health Science Center, San Antonio
Received 24 May 2006; received in revised form 27 September 2006; accepted 9 October 2006
Abstract
Background: The characteristics associated with meeting goals for glycemia, blood pressure (BP), and low-density lipoprotein (LDL)
cholesterol for participants with diabetes were examined. Methods: Baseline information on demographics, medical history, and
anthropometry, as well as on hemoglobin A1c, BP, and LDL cholesterol levels, was measured in 5145 participants of Look AHEAD, a
multicenter randomized trial performed to determine whether long-term weight loss and increased physical fitness reduce cardiovascular
disease (CVD) in overweight and obese individuals with type 2 diabetes. Logistic regression was used to analyze these cross-sectional data to
ascertain associations between participant characteristics and attainment of risk factor goals [hemoglobin A1c b7.0%, BP b130/80 mmHg,
and LDL b100 mg/dl]. Results: The study population had a mean age of 58.7 years and a mean body mass index of 36.0 kg/m2. Of the total
number of participants, 59.5% were female, 36.8% were of ethnic/racial minority, and 87.3% were on diabetes medications. Upon
enrollment, 45.8% had hemoglobin A1cb7.0%, 51.7% had BPb130/80 mmHg, and 37.2% had LDLb100 mg/dl. All three goals were met by
only 10.1%. We found consistent evidence for differences in risk factor control by age, gender, race/ethnicity, degree of obesity, education,
income, CVD, source of medical care, and medication use. In multivariable analysis, African-American race, increasing degree of obesity,
insulin use, and nonutilization of a lipid-lowering agent were associated with not meeting all risk factor goals. Conclusion: These data
demonstrate that numerous baseline characteristics are associated with suboptimal control of these cardiovascular risk factors among
overweight and obese adults with diabetes.
D 2008 Elsevier Inc. All rights reserved.
Keywords: Hemoglobin A1c; Blood pressure; Cholesterol; Risk factor control
1. Introduction
4 Corresponding author. Public Health Sciences, Medical Center
Boulevard, Winston-Salem, NC 27157, USA. Tel.: +1 336 716 2824;
fax: +1 336 713 4300.
E-mail address: abertoni@wfubmc.edu (A.G. Bertoni).
1056-8727/08/$ see front matter D 2008 Elsevier Inc. All rights reserved.
doi:10.1016/j.jdiacomp.2006.10.003
2. Methods
Look AHEAD (Action for Health in Diabetes) is a
multicenter randomized trial performed to determine, among
overweight and obese volunteers with type 2 diabetes, the
long-term effects of two study conditions: an intensive
lifestyle intervention designed to achieve and maintain
weight loss by decreased caloric intake and increased
physical activity versus a control condition (diabetes support
and education) on the combined incidence of serious CVD
events (cardiovascular death, nonfatal myocardial infarction,
and nonfatal stroke). Details regarding study design
and rationale have been published (Ryan et al., 2003).
Participants included persons with type 2 diabetes aged
4574 years with a body mass index (BMI) z25 kg/m2
(z27 kg/m2 if on insulin) who were recruited from 16 US
centers from August 2001 to April 2004. Persons with
hemoglobin A1c N11%, BP z160/100 mmHg, triglycerides
z600 mg/dl, and weight N350 lb were excluded, as
were persons with recent weight loss, recent use of weight
control medication, or past weight loss surgery. Persons
meeting these criteria were additionally screened with an
exercise stress test; those with normal results were random-
Table 1
Baseline characteristics of the Look AHEAD clinical trial cohort (N=5145)
Characteristics
3. Results
The baseline characteristics of randomized persons are
presented in Table 1. A majority of participants were
women; 36.8% were members of ethnic/racial minority
groups. Nearly all (85.1%) were obese (BMIz30), with the
remainder being overweight. Most participants were on
diabetes medications, including 18.7% who were using
insulin; many also reported taking antihypertensives and
lipid-lowering drugs.
3.1. Univariate analyses
The mean hemoglobin A1c was 7.3%, the mean BP was
129/70 mmHg, and the mean LDL cholesterol was
112 mg/dl. Control to ADA goal levels was modest (blood
glucose, 45.8%; BP, 51.5%; LDL cholesterol, 37.2%). Only
10.1% had all three factors under optimal control. The
proportion of participants meeting each and all three goals
according to selected characteristics is presented in Table 2.
We found evidence for differential control by age, gender,
race/ethnicity, and use of medication. Participants reporting
no use of diabetes medication were more likely to meet
goals (except for LDL) than either those on oral hypoglycemic agents or those on insulin. Among those reporting
any medication use, control of hemoglobin A1c was
observed in 42.3%, control of BP was observed in 51%,
control of LDL was observed in 38.7%, and control of all
three was observed in 9.7%. Older persons more frequently
met hemoglobin A1c and LDL goals but less frequently met
BP goal than younger participants. Women less frequently
met LDL goal. African-Americans were less likely to meet
individual (and all) goals, whereas Native Americans more
frequently met BP and LDL goals compared to Whites.
Fewer of the most obese individuals reached hemoglobin
A1c, BP, and all goals compared to overweight participants.
Other variables associated with differential hemoglobin
A1c control included income and education, usual source of
care, duration of diabetes, and CVD history. BP control was
somewhat more likely among those reporting a hospital
clinic or a community health center as the usual source of
care, and among those not reporting BP or diabetes
medication use. Additional variables associated with meeting LDL goal included education, CVD, duration of
diabetes, use of antihypertensive or lipid-lowering medications, and regular aspirin use.
3.2. Multivariable analyses
The variables that remained significant for hemoglobin
A1c control are presented in Table 3. The relationship
between age and hemoglobin A1c control was modified by
1620 (31.5)
2650 (51.5)
874 (17.0)
58.7F6.8
3063 (59.5)
3245
804
677
258
50
98
(63.2)
(15.7)
(13.2)
(5.0)
(1.0)
(1.9)
1024 (20.4)
1911 (38.0)
2093 (41.6)
589
1476
1212
1359
(11.4)
(28.7)
(23.6)
(26.4)
3780
635
398
290
23
(73.5)
(12.3)
(7.7)
(5.6)
(0.4)
768 (14.9)
1815 (35.3)
1411 (27.4)
1151 (22.4)
36.0F5.9
2327 (45.2)
228 (4.4)
6.8F6.5
726 (14.1)
963 (18.7)
3426 (66.6)
695 (13.5)
4149 (80.6)
3541 (68.8)
2448 (47.6)
2360 (45.9)
Table 2
Proportion meeting ADA goals for glycemia, BP, and LDL cholesterol, by
selected participant characteristics
Characteristics
Hemoglobin
A1c
Gender
Male
46.2
Female
45.6
P
.7
Age in years
4555
41.5
5665
46.9
6676
50.5
P
b.001
Race/ethnicity
White
49.2
African-American
39.4
Hispanic
38.4
American Indian
41.5
Asian/Pacific Islander
44.0
Other/mixed
48.0
P
b.001
Education in years
b13
39.6
1316
45.5
N16
49.3
P
b.001
BMI in kg/m2
b30
50.4
3034
47.8
3539
43.1
z40
42.9
P
b.001
Years since diabetes diagnosis
b2
64.8
25
46.3
N5
33.2
P
b.001
Income in US$
b20,000
41.1
20,00049,999
43.4
50,00079,999
47.0
N80,000
47.1
P
.02
History of CVD
Not reported
46.8
Reported
40.1
P
b.001
Source of health care
Private doctors office
48.2
Hospital clinic or
41.3
outpatient department
Community health center 33.9
Other kind of health
41.7
care facility
No usual source of care
34.8
P
b.001
Diabetes treatment
Insulin
25.5
Oral medication alone
47.0
No diabetes medication
67.9
P
b.001
Lipid-lowering medication
Not reported
45.8
Reported
45.7
P
.9
BP
LDL
cholesterol
All
50.5
52.3
.2
43.3
33.0
b.001
11.5
9.1
b.01
55.4
51.4
45.2
b.001
33.1
37.4
44.2
b.001
9.1
10.2
11.6
b.001
51.7
45.8
54.9
63.2
56.0
39.8
b.001
38.9
29.3
35.6
48.1
37.5
30.2
b.001
11.6
5.1
7.9
12.2
12.5
9.4
b.001
52.4
51.8
51.3
.8
33.9
37.4
38.1
.8
8.3
9.4
11.6
b.01
59.2
55.5
48.1
44.4
b.001
35.5
40.0
34.3
37.2
.8
14.1
11.1
8.5
7.7
b.001
52.8
51.9
50.7
.4
31.5
36.8
41.4
b.001
12.3
10.6
8.3
b.001
52.1
50.3
52.1
52.2
.7
35.9
37.6
37.2
38.3
.8
8.1
10.4
10.5
10.5
.4
51.5
52.2
.7
34.7
52.3
b.001
9.8
11.7
.1
50.4
55.4
37.1
40.4
10.6
10.2
56.5
50.3
32.6
36.6
8.6
6.3
65.2
.02
39.1
.2
4.3
.1
49.4
51.4
55.3
.06
41.7
37.8
28.2
b.001
7.5
10.3
12.7
b.01
50.5
52.7
.1
23.9
51.5
b.001
5.8
14.7
b.001
Table 2 (continued)
Characteristics
BP medication
Not reported
Reported
P
Regular aspirin use
Not reported
Reported
P
Hemoglobin
A1c
BP
LDL
cholesterol
All
46.0
45.7
.8
57.8
48.8
b.001
29.2
40.7
b.001
9.5
10.4
.3
46.5
45.0
.3
51.2
51.9
.6
31.0
44.3
b.001
8.8
11.7
b.001
Table 3
Results of multivariable analysis of characteristics associated with control
of hemoglobin A1c at b7%a
Characteristic
b.001
b.001
.01
b.01
.01
Results are for variables in the final model. Variables not listed were
not entered into the final model. P values given are for the effect of the
variable on the model. ORs listed are compared to the reference category
within the variable.
444 Pb.001.
44 Pb.01.
Table 4
Results of multivariable analyses of characteristics associated with control of BP (b130/80) and LDL (b100 mg/dl), and simultaneous control of hemoglobin
A1c, BP, and LDL cholesterol according to ADA-recommended goalsa
BP
Characteristics
OR
(95% confidence interval)
Duration of diabetes
Oral medication
BP medication
0.77444 (0.680.87)
Lipid-lowering medication
LDL
P
b.001
.001
b.001
All
OR
(95% confidence interval)
0.76444 (0.670.87)
0.814 (0.680.98)
2.33444 (1.713.17)
1.20 (0.632.27)
1.16 (0.961.40)
0.32 (0.071.52)
0.81 (0.511.30)
1.274 (1.041.50)
1.014 (1.001.02)
1.32444 (1.151.53)
3.04444 (2.673.47)
1.27444 (1.111.42)
OR
(95% confidence interval)
b.001
0.51444 (0.360.71)
1.534 (1.02.35)
1.06 (0.442.56)
0.78 (0.571.06)
0.79 (0.16.31)
0.93 (0.461.89)
b.001
1.85444 (1.362.52)
b.001
1.384 (1.051.80)
1.10 (0.821.48)
2.05444 (1.452.89)
b.001
1.5044 (1.141.97)
2.87444 (2.333.53)
a
Results are for variables in the final model. Variables not listed were not entered into the final model. P values given are for the effect of the variable on
the model. ORs listed are compared to the reference category within the variable.
4 Pb.05.
44 Pb.01.
444 Pb.001.
4. Discussion
These data demonstrate suboptimal control of glycemia,
BP, and LDL cholesterol among type 2 diabetic subjects
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