We examined the control of modifiable risk factors among a national sample of diabetic people with and without lower extremity disease (LED).
The sample from the 1999-2004 National Health and Nutrition Examination Survey consisted of 948 adults aged 40 years or older with diagnosed diabetes and who had been assessed for LED. LED was defined as peripheral arterial disease (ankle-brachial index <0.9), peripheral neuropathy (≥1 insensate area), or presence of foot ulcer. Good control of modifiable risk factors, based on American Diabetes Association recommendations, included being a nonsmoker and having the following measurements: HbA1c less than 7%, systolic blood pressure less than or equal to 130 mm Hg, diastolic blood pressure less than or equal to 80 mm Hg, high density lipoprotein (HDL) cholesterol greater than 50 mg/dL, and body mass index (BMI) between 18.5 kg/m2 and 24.9 kg/m2.
Diabetic people with LED were less likely than were people without LED to have recommended levels of HbA1c (39.3% vs 53.5%) and HDL cholesterol (29.7% vs 41.1%), but there were no differences in systolic or diastolic blood pressure, BMI classification, or smoking status between people with and without LED. Control of some risk factors differed among population subgroups. Notably, among diabetic people with LED, non-Hispanic blacks were more likely to have improper control of HbA1c (adjusted odds ratio [AOR] = 2.0; 95% confidence interval [CI], 1.1-3.9), systolic blood pressure (AOR = 1.9; 95% CI, 1.1-3.2), and diastolic blood pressure (AOR = 2.6; 95% CI, 1.1-5.8), compared with non-Hispanic whites.
Control of 2 of 6 modifiable risk factors was worse in diabetic adults with LED compared with diabetic adults without LED. Among diabetic people with LED, non-Hispanic blacks had worse control of 3 of 6 risk factors compared with non-Hispanic whites.
People who have diabetes are at an increased risk for developing lower extremity disease (LED), which includes peripheral arterial disease (PAD) and peripheral neuropathy (PN) (
People with LED are at increased risk for coronary heart disease and stroke. Prospective studies have shown PAD, measured by the ankle-brachial index (ABI), predicts subsequent myocardial infarction and cardiovascular mortality (
For diabetic adults with LED, improved control of modifiable risk factors may reduce the risk of progression to late-stage disease, which is responsible for the majority of health care expenditures, morbidity, mortality, and disability among people with diabetes. Lack of tightly controlled blood glucose, blood pressure, and cholesterol can put people with diabetes at an increased risk for long-term complications (
Evaluating the associations between LED and modifiable risk factors among diabetic people with LED may identify intervention opportunities to prevent late-stage disease. Our objectives were to examine a nationally representative sample of people with diagnosed diabetes to 1) describe the prevalence of modifiable risk factors for people with and without LED, and 2) identify factors specifically associated with poor control of modifiable risk factors, stratified by LED presence or absence.
The National Health and Nutrition Examination Survey (NHANES) is a national population-based survey designed to assess the health and nutritional status of civilian, noninstitutionalized people older than age 2 months in the United States (
People aged 40 years or older who completed both the in-person interview and medical examination were assessed for the presence of LED, which included tests for PAD and PN, as well as physical inspection for foot lesions and abnormalities. Among people aged 40 years or older with diagnosed diabetes, 15 people with lower extremity amputations were excluded from analyses (1 non-Hispanic white, 5 non-Hispanic blacks, and 9 Mexican Americans). Participants with an ABI at or above 1.5 in both legs or in 1 leg if the ABI measurement for the opposite leg was missing were excluded because they may have medial arterial perfusion, which prevents accurate ABI measurement. Data on PAD for both feet were missing for 176 participants with diagnosed diabetes (15.2%), and data on PN for both feet were missing for 55 participants with diagnosed diabetes (2.9%) because of equipment failure, participant refusal, time constraints for physical examination, inability of respondent to undergo LED assessment, or other unspecified cause. Thus, 984 people were assessed for PAD, 1,105 were assessed for PN, and of these 948 had an assessment for both PAD and PN (83.1% of adults aged ≥40 with diagnosed diabetes).
PAD was assessed using the ABI, which is the ratio of systolic blood pressure in the ankles (posterior tibial vessels) to that in the right arm (right brachial vessel) (Parks Mini-Lab IV, Model 3100, Parks Medical Electronics, Inc, Aloha, Oregon) (
PN was assessed by testing foot sensation with the Semmes Weinstein monofilament (5.07-gauge nylon Semmes Weinstein monofilament, Mid-Delta Health Systems, Inc, Belzoni, Mississippi). Pressure was applied to each foot with the monofilament at 3 sites (plantar: first metatarsal head, fifth metatarsal head, and hallux). The monofilament was applied at each site until it buckled and then held for 1 second. A random forced-response method was used to determine whether the participant could feel the monofilament. A site was considered insensate if a person incorrectly identified when the monofilament was placed on that area of the foot for 2 of 3 applications. Participants with 1 or more insensate area (0-6 possible) were considered to have PN. Research has shown 1 or more insensate area to be predictive of amputation and foot ulcers, with strong specificity and sensitivity (
During the physical examination, participants' feet were visually examined by health technicians for any abnormalities. Participants with foot ulcers were also considered to have LED. Individuals with amputations (toe or foot; 1 leg or both legs) were excluded from analyses (n = 15) because they were considered to already have late-stage disease, and the purpose of this study is to examine prevalence of modifiable risk factors in earlier stages of disease (ie, PN and PAD).
Race and ethnicity were self-reported. We restricted race/ethnicity-specific analyses to non-Hispanic white, non-Hispanic black, and Mexican Americans due to limited sample size of other races. Covariates investigated include age, health insurance status, sex, and education level. Education was categorized as high school education or less, including certificate of general education development (GED), or some college or greater.
To evaluate control of risk factors among diabetic people with LED, the American Diabetes Association (ADA) Standards of Medical Care in Diabetes recommendations were used to establish variables that indicate levels of diabetic control (
All estimates were weighted using NHANES sample weights. SAS version 9.1.3 (SAS Institute Inc, Cary, North Carolina) was used for data management, and SUDAAN version 9 (RTI International, Research Triangle Park, North Carolina) was used to account for the complex sampling scheme.
Of 948 eligible participants, 365 had LED. Data on LED were missing for 212 diabetic people aged 40 years or older. Compared with respondents without missing LED data, those with missing LED information were more likely to have less than a high school education (46.6% vs 29.8%,
Approximately 35% of diabetic people aged 40 years or older had LED. Among people with diabetes, 33.4% of non-Hispanic whites, 38.9% of non-Hispanic blacks and 31.9% of Mexican Americans had LED (
The prevalence of 4 of 6 risk factors did not differ significantly between those with and without LED: systolic blood pressure at or above 130 mm Hg, diastolic blood pressure at or above 80 mm Hg, obese BMI, and current smoking (
Among diabetic adults with LED, non-Hispanic blacks were significantly more likely than non-Hispanic whites to have HbA1c levels at or above 7%, systolic blood pressure values at or above 130 mm Hg, and diastolic blood pressure values at or above 80 mm Hg (
Racial/ethnic differences in diabetes control were also observed among diabetic people without LED. Non-Hispanic blacks without LED were more likely to have uncontrolled diastolic blood pressure control (AOR = 2.2; 95% CI, 1.0-4.5) compared with non-Hispanic whites. Among those without LED, Mexican Americans were more likely to have HbA1c at or above 7% (AOR = 2.7; 95% CI, 1.8-4.1) compared with non-Hispanic whites. No significant associations were found between race/ethnicity and systolic blood pressure, HDL cholesterol, smoking behavior, or weight control for respondents without LED.
Sex and education level differences in risk factor control according to LED status were also observed in logistic modeling. Among people with and without LED, men were more likely to have HDL cholesterol at or below 50 mg/dL after adjusting for age, race/ethnicity, health insurance status, and education level (
Approximately one-third of participants aged 40 years or older with diabetes had LED. A similar prevalence of risk factor control at the ADA-recommended level was observed in participants with and without LED for 4 of 6 measures (systolic blood pressure, diastolic blood pressure, BMI, and smoking status). People with LED had a significantly lower prevalence of risk factor control at the ADA recommended level compared with those without LED in 2 of 6 measures (HbA1c and HDL cholesterol).
In our study, people with LED were less likely to have tight glycemic and lipid control than were those without LED. Although incomplete success controlling these risk factors was observed in both groups, the implications may be worse for people with LED because they are at increased risk for cardiovascular events and amputation. Poor glycemic control has been associated with increased susceptibility to foot infection and poor wound healing among people with diabetes (
Among participants with LED, we found racial/ethnic differences in the level of a few risk factors that could influence progression to amputation and other cardiovascular outcomes. Non-Hispanic blacks were less likely to have adequate glycemic control and blood pressure control than were non-Hispanic whites, but no differences were observed for HDL control. Unlike non-Hispanic blacks, Mexican Americans had no differences in level of risk factor control among people with LED compared with non-Hispanic whites.
Racial/ethnic differences in late-stage disease have been observed. Data from the National Hospital Discharge Survey have shown that whites with diabetes have a lower rate of nontraumatic amputations than do blacks with diabetes (
Low education level was associated with an increased risk for poor control of modifiable risk factors among people with and without LED. This finding is similar to those of previous reports that have documented a higher prevalence of cardiovascular disease risk factors in people with less than high school education compared with people with some college education or greater (
Our findings have implications for national diabetes objectives.
Our study has several limitations. First, only noninvasive tests were used to measure PAD and PN. Although more comprehensive tests may provide more accurate diagnostic testing, both the ABI test for PAD and the monofilament test for PN have been shown to have high degrees of both sensitivity and specificity (
Our study provides the first estimates of modifiable risk factors among diabetic people with and without LED using nationally representative data. Our data show a higher prevalence of 2 of 6 modifiable risk factors studied that may affect progression to late-stage disease among diabetic adults with LED compared with those without LED. Our findings also show different levels of risk factor control for some risk factors among racial/ethnic groups with diabetes and LED. Exploring the potential role of risk factor control among people with LED may reduce amputations and cardiovascular events and may help explain and possibly reduce the observed racial/ethnic disparity in amputations.
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Characteristics of People With Diagnosed Diabetes Aged 40 Years or Older, By LED Status, National Health and Nutrition Examination Survey, 1999-2004
| LED Present (N = 365) | LED Absent (N = 583) | ||
|---|---|---|---|
| 63.8 (0.92) | 59.0 (0.54) | <.001 | |
| Male | 64.6 (55.4-72.8) | 48.2 (43.2-53.2) | <.001 |
| Female | 35.4 (27.2-44.6) | 51.8 (46.8-56.8) | |
| Less than high school education | 30.7 (21.9-41.2) | 25.5 (21.8-29.7) | .10 |
| High school or GED | 32.1 (23.7-41.8) | 23.7 (19.1-29.0) | |
| Some college or greater | 37.2 (28.0-47.6) | 50.8 (45.2-56.3) | |
| Present | 93.4 (88.8-96.2) | 88.5 (84.9-91.3) | .40 |
| Absent | 6.6 (3.8-11.2) | 11.5 (8.7-15.1) | |
| Non-Hispanic white | 72.7 (62.9-80.7) | 74.5 (67.4-80.5) | .25 |
| Non-Hispanic black | 18.5 (12.5-26.6) | 15.7 (11.5-26.6) | |
| Mexican American | 8.8 (5.2-14.5) | 9.8 (6.4-14.8) | |
Abbreviations: LED, lower extremity disease; SE, standard error; CI, confidence interval; GED, general education development certificate.
Weighted estimates.
Age-standardized to the 2000 US population.
Prevalence of Modifiable Risk Factors for People With Diagnosed Diabetes Aged 40 Years or Older, by LED Status, National Health and Nutrition Examination Survey, 1999-2004
| Sample Size | LED Present (N = 365), % (95% CI) | LED Absent (N = 583), % (95% CI) | ||
|---|---|---|---|---|
| <7 | 458 | 39.3 (31.5-47.8) | 53.5 (48.2-58.6) | .03 |
| ≥7 | 458 | 60.7 (52.3-68.5) | 46.5 (41.4-51.8) | |
| <130 | 405 | 51.8 (42.2-61.3) | 49.2 (42.3-57.8) | .30 |
| ≥130 | 514 | 48.2 (38.7-56.2) | 50.8 (43.8-57.7) | |
| <80 | 740 | 73.5 (64.0-81.3) | 74.2 (68.5-79.2) | .80 |
| ≥80 | 179 | 26.5 (18.7-36.0) | 25.8 (20.8-31.5) | |
| >50 | 356 | 29.7 (20.3-41.2) | 41.1 (34.5-48.0) | .04 |
| ≤50 | 560 | 70.3 (58.8-79.7) | 58.9 (52.0-65.5) | |
| Healthy | 149 | 12.7 (7.3-21.0) | 17.6 (13.2-23.0) | .09 |
| Overweight | 351 | 29.2 (21.1-38.9) | 31.7 (25.2-38.9) | |
| Obese | 430 | 58.1 (48.3-67.4) | 50.7 (42.9-58.6) | |
| Never | 431 | 40.9 (33.5-48.8) | 47.7 (41.0-54.5) | .43 |
| Former | 357 | 33.8 (27.0-41.3) | 32.8 (28.0-37.9) | |
| Current | 160 | 25.3 (16.8-36.1) | 19.5 (16.3-24.1) | |
Abbreviations: LED, lower extremity disease; CI, confidence interval; HbA1c, hemoglobin A1c; HDL, high-density lipoprotein; BMI, body mass index.
Age-standardized to the 2000 US population; percentages are weighted.
Some cell sample sizes may not add to 948 because of missing data.
See Methods section for subgroup definitions.
Odds of Modifiable Risk Factors for Adults With Diagnosed Diabetes, by LED Status, National Health and Nutrition Examination Survey, 1999-2004
| Female | 1 [Reference] | 1 [Reference] |
| Male | 0.9 (0.5-1.8) | 0.8 (0.5-1.3) |
| Non-Hispanic white | 1 [Reference] | 1 [Reference] |
| Non-Hispanic black | 2.0 (1.1-3.9) | 1.6 (1.0-2.7) |
| Mexican American | 1.1 (0.5-2.5) | 2.7 (1.8-4.1) |
| Some college or greater | 1 [Reference] | 1 [Reference] |
| Less than high school | 1.5 (0.6-3.9) | 1.3 (0.7-2.4) |
| High school graduate or GED | 1.3 (0.5-3.1) | 0.9 (0.5-1.9) |
| Absent | 1 [Reference] | 1 [Reference] |
| Present | 0.8 (0.3-2.3) | 0.9 (0.3-2.4) |
| Female | 1 [Reference] | 1 [Reference] |
| Male | 0.6 (0.3-1.1) | 0.8 (0.5-1.3) |
| Non-Hispanic white | 1 [Reference] | 1 [Reference] |
| Non-Hispanic black | 1.9 (1.1-3.2) | 1.3 (0.8-2.3) |
| Mexican American | 0.9 (0.5-1.9) | 0.8 (0.4-1.6) |
| Some college or greater | 1 [Reference] | 1 [Reference] |
| Less than high school | 1.6 (0.7-3.7) | 1.9 (1.1-3.1) |
| High school graduate or GED | 0.8 (0.3-1.7) | 1.7 (0.8-3.5) |
| Absent | 1 [Reference] | 1 [Reference] |
| Present | 1.5 (0.5-4.3) | 1.3 (0.6-2.8) |
| Female | 1 [Reference] | 1 [Reference] |
| Male | 1.8 (0.7-4.3) | 1.5 (0.8-3.0) |
| Non-Hispanic white | 1 [Reference] | 1 [Reference] |
| Non-Hispanic black | 2.6 (1.1-5.8) | 2.2 (1.0-4.5) |
| Mexican American | 0.4 (0.1-1.8) | 1.2 (0.5-2.8) |
| Some college or greater | 1 [Reference] | 1 [Reference] |
| Less than high school | 1.4 (0.5-4.1) | 1.7 (0.9-3.3) |
| High school graduate or GED | 0.4 (0.1-1.3) | 1.6 (0.7-3.9) |
| Absent | 1 [Reference] | 1 [Reference] |
| Present | 0.2 (0.1-1.1) | 0.5 (0.2-1.1) |
| Female | 1 [Reference] | 1 [Reference] |
| Male | 3.2 (1.4-7.4) | 2.7 (1.4-5.3) |
| Non-Hispanic white | 1 [Reference] | 1 [Reference] |
| Non-Hispanic black | 0.4 (0.1-1.3) | 1.0 (0.5-1.9) |
| Mexican American | 0.6 (0.2-1.9) | 0.7 (0.2-2.0) |
| Some college or greater | 1 [Reference] | 1 [Reference] |
| Less than high school | 0.8 (0.3-2.2) | 2.0(1.1-3.9) |
| High school graduate or GED | 0.3 (0.1-1.3) | 1.4 (0.7-2.9) |
| Absent | 1 [Reference] | 1 [Reference] |
| Present | 0.2 (0.1-0.9) | 2.4 (0.7-8.1) |
| Female | 1 [Reference] | 1 [Reference] |
| Male | 2.7 (0.9-8.0) | 1.0 (0.6-1.7) |
| Non-Hispanic white | 1 [Reference] | 1 [Reference] |
| Non-Hispanic black | 0.8 (0.3-2.0) | 1.8 (1.0-3.5) |
| Mexican American | 0.4 (0.2-1.8) | 0.7 (0.3-1.5) |
| Some college or greater | 1 [Reference] | 1 [Reference] |
| Less than high school | 4.5 (1.8-11.2) | 1.6 (0.8-3.0) |
| High school graduate or GED | 1.4 (0.5-3.4) | 1.9 (1.0-3.6) |
| Absent | 1 [Reference] | 1 [Reference] |
| Present | 0.4 (0.1-1.8) | 0.5 (0.2-1.2) |
| Female | 1 [Reference] | 1 [Reference] |
| Male | 1.0 (0.4-2.3) | 0.8 (0.4-1.4) |
| Non-Hispanic white | 1 [Reference] | 1 [Reference] |
| Non-Hispanic black | 0.7 (0.3-1.8) | 1.8 (0.9-3.4) |
| Mexican American | 0.4 (0.2-1.0) | 1.4 (0.7-2.9) |
| Some college or greater | 1 [Reference] | 1 [Reference] |
| Less than high school | 0.4 (0.1-1.3) | 1.9 (1.0-3.8) |
| High school graduate or GED | 0.3 (0.1-1.0) | 1.6 (0.8-3.3) |
| Absent | 1 [Reference] | 1 [Reference] |
| Present | 1.0 (0.2-5.5) | 2.4 (1.0-5.8) |
Abbreviations: LED, lower extremity disease; AOR, adjusted odds ratio; CI, confidence interval; GED, general educational development certificate; HDL, high-density lipoprotein.
All models adjusted for age.
Confidence intervals may begin with 1 because of rounding.
See Methods section for definitions.