Table of Contents

Component Description

Diabetes is a leading cause of disease and death in the United States. Eight million Americans are known to have diabetes, and an approximately equal number have undiagnosed diabetes. In 1993, nearly 18 percent of all deaths, for persons over the age of 25, were among people with diabetes. Substantial new efforts to prevent or control diabetes have begun, including the Diabetes Prevention Trial and the National Diabetes Education Program.

Diabetes testing provides population data to: 1) determine a national estimate of diabetes disease prevalence (diagnosed and undiagnosed); 2) identify the risk factors of diabetes disease; 3) permit a national cohort to be established for follow-up studies of this condition; and 4) provide critical information to clinicians and public health officials for the development of preventive care and community-based interventions.

Eligible Sample

Examined participants aged 12 years and older who were examined in the morning session and met a 9 hour fast, were eligible.

Description of Laboratory Methodology

Plasma specimens were processed, stored and shipped to the University of Missouri, Columbia, MO for analysis.

Glucose concentration was determined by a hexokinase method. It is an endpoint enzymatic method with a sample blank correction.

Oral Glucose Tolerance Test

Testing of an oral glucose tolerance test (OGTT) continued in 2013-2014. A fasting glucose blood test was performed on all participants 12 years and older, who were examined in the morning session after a nine-hour fast. After the initial venipuncture, participants were asked to drink a calibrated dose (generally 75 grams of glucose) of TrutolTM and had a second venipuncture 2 hours (plus or minus 15 minutes) after drinking the TrutolTM.

There are seven exclusion criteria, including hemophilia and chemotherapy safety exclusions, fasting less than 9 hours, taking insulin or oral medications for diabetes, refusing phlebotomy, and not drinking the entire Trutol™ solution within the allotted time.
Refer to the Laboratory Method Files section for detailed laboratory procedure manual(s) of the methods used.

There were changes to the lab method, lab equipment, and lab site for this component in the NHANES 2013-2014 cycle. In the 2011-2012 cycle, the University of Minnesota performed this testing. The University of Missouri-Columbia began testing plasma glucose in the 2013-2014 cycle.

Laboratory Method Files

Oral Glucose Tolerance (January 2016)

Laboratory Quality Assurance and Monitoring

Plasma specimens were processed, stored and shipped to the University of Missouri, Columbia, MO for analysis.

Detailed instructions on specimen collection and processing are discussed in the NHANES Laboratory Procedures Manual (LPM). Vials are stored under appropriate frozen (–70°C) conditions until they are shipped to University of Missouri for testing.

The NHANES quality assurance and quality control (QA/QC) protocols meet the 1988 Clinical Laboratory Improvement Amendments mandates. Detailed QA/QC instructions are discussed in the NHANES LPM.

Mobile Examination Centers (MECs)

Laboratory team performance is monitored using several techniques. NCHS and contract consultants use a structured quality assurance evaluation during unscheduled visits to evaluate both the quality of the laboratory work and the quality-control procedures. Each laboratory staff member is observed for equipment operation, specimen collection and preparation; testing procedures and constructive feedback are given to each staff member. Formal retraining sessions are conducted annually to ensure that required skill levels were maintained.

Analytical Laboratories

NHANES uses several methods to monitor the quality of the analyses performed by the contract laboratories. In the MEC, these methods include performing blind split samples collected on “dry run” sessions. In addition, contract laboratories randomly perform repeat testing on 2.0% of all specimens.

NCHS developed and distributed a quality control protocol for all the contract laboratories which outlined the use of Westgard rules (Westgard et al, 1981) when running NHANES specimens. Progress reports containing any problems encountered during shipping or receipt of specimens, summary statistics for each control pool, QC graphs, instrument calibration, reagents, and any special considerations are submitted to NCHS quarterly. The reports are reviewed for trends or shifts in the data. The laboratories are required to explain any identified areas of concern.

All QC procedures recommended by the manufacturers were followed. Reported results for all assays meet the University of Missouri’s quality control and quality assurance performance criteria for accuracy and precision, similar to the Westgard rules.

Data Processing and Editing

The data were reviewed. Incomplete data or improbable values were sent to the performing laboratory for confirmation.

One calculated variable was created in this data file. The variable was created using the following formula:

LBXGLT and LBDGLTSI:

The two-hour (OGTT), glucose value in mg/dL (LBXGLT) was converted to mmol/L (LBDGLTSI) by multiplying by 0.05551 (rounded to 3 decimals).

Analytic Notes

Refer to the 2013-2014 Laboratory Data Overview for general information on NHANES laboratory data.

Sampling Weights

The analyst is strongly encouraged to use the OGTT sampling weights in this file to analyze 2013–2014 two-hour (OGTT) glucose levels.

There will be two weight variables associated with the subsample for the diabetes data. Use the fasting sample weights (WTSFA2YR) when analyzing the fasting glucose and insulin levels only. Use the OGTT sample weights (WTSOG2YR) when analyzing the insulin, fasting AND OGTT glucose levels or when analyzing ONLY OGTT glucose levels. NOTE: the fasting glucose and insulin weights and data are in separate files (GLU_H and INS_H, respectively).

Demographic and Other Related Variables

The analysis of NHANES laboratory data must be conducted using the appropriate survey design and demographic variables. The NHANES 2013-2014 Demographics File contains demographic data, health indicators, and other related information collected during household interviews as well as the sample design variables. The recommended procedure for variance estimation requires use of stratum and PSU variables (SDMVSTRA and SDMVPSU, respectively) in the demographic data file.

The Fasting Questionnaire File includes auxiliary information such as fasting status, the time of venipuncture, and the conditions precluding venipuncture.

This laboratory data file can be linked to the other NHANES data files using the unique survey participant identifier (i.e., SEQN).

Variables that should help the user in the analysis of the two-hour glucose tolerance data include:

GTDSCMMN: used to define
           "Glucose challenge Administer Time in minutes".
GTDDR1MN: used to define:
           "Time from fast glucose & challenge (min)"
GTDBL2MN: used to define:
           "Time from fasting glucose & OGTT (min)"
GTDDR2MN: used to define:
           "Time from glucose challenge & OGTT (min)"
GTXDRANK: used to define:
           "Amount of glucose challenge the SP drank"
GTDCODE: used to define:
           "Incomplete OGTT Comment Code"

Detection Limits

The detection limit was constant for this analyte in the data set. The variable prefixed LBX (ex., LBXGLT) provides the analytic result for that analyte.

The lower limit of detection (LLOD, in mg/dL) for OGTT glucose is:

Variable Name SAS Label  LLOD
LBXGLT  OGTT glucose      2.0

Please refer to the NHANES Analytic Guidelines and the on-line NHANES Tutorial for further details on the use of sample weights and other analytic issues.

References

Codebook and Frequencies

SEQN - Respondent sequence number

Variable Name:
SEQN
SAS Label:
Respondent sequence number
English Text:
Respondent sequence number.
Target:
Both males and females 12 YEARS - 150 YEARS

WTSOG2YR - OGTT Subsample 2 Year MEC Weight

Variable Name:
WTSOG2YR
SAS Label:
OGTT Subsample 2 Year MEC Weight
English Text:
OGTT Subsample 2 Year MEC Weight
Target:
Both males and females 12 YEARS - 150 YEARS
Code or Value Value Description Count Cumulative Skip to Item
15353.54074 to 415382.80096 Range of Values 2600 2600
0 No Lab Result 309 2909
. Missing 0 2909

LBXGLT - Two Hour Glucose(OGTT) (mg/dL)

Variable Name:
LBXGLT
SAS Label:
Two Hour Glucose(OGTT) (mg/dL)
English Text:
Two Hour Glucose(OGTT) (mg/dL)
Target:
Both males and females 12 YEARS - 150 YEARS
Code or Value Value Description Count Cumulative Skip to Item
40 to 604 Range of Values 2345 2345
. Missing 564 2909

LBDGLTSI - Two Hour Glucose(OGTT) (mmol/L)

Variable Name:
LBDGLTSI
SAS Label:
Two Hour Glucose(OGTT) (mmol/L)
English Text:
Two Hour Glucose(OGTT) (mmol/L)
Target:
Both males and females 12 YEARS - 150 YEARS
Code or Value Value Description Count Cumulative Skip to Item
2.22 to 33.528 Range of Values 2345 2345
. Missing 564 2909

GTDSCMMN - Glucose challenge Administer Time in min

Variable Name:
GTDSCMMN
SAS Label:
Glucose challenge Administer Time in min
English Text:
Glucose challenge Administer Time in minutes
Target:
Both males and females 12 YEARS - 150 YEARS
Code or Value Value Description Count Cumulative Skip to Item
0 to 53 Range of Values 2409 2409
. Missing 500 2909

GTDDR1MN - Time from fast glucose & challenge(min)

Variable Name:
GTDDR1MN
SAS Label:
Time from fast glucose & challenge(min)
English Text:
Time from fast glucose & challenge(min)
Target:
Both males and females 12 YEARS - 150 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 to 74 Range of Values 2409 2409
. Missing 500 2909

GTDBL2MN - Time from fasting glucose & OGTT (min)

Variable Name:
GTDBL2MN
SAS Label:
Time from fasting glucose & OGTT (min)
English Text:
Time from fasting glucose & OGTT (min)
Target:
Both males and females 12 YEARS - 150 YEARS
Code or Value Value Description Count Cumulative Skip to Item
42 to 183 Range of Values 2346 2346
. Missing 563 2909

GTDDR2MN - Time from glucose challenge & OGTT(min)

Variable Name:
GTDDR2MN
SAS Label:
Time from glucose challenge & OGTT(min)
English Text:
Time from glucose challenge & OGTT(min)
Target:
Both males and females 12 YEARS - 150 YEARS
Code or Value Value Description Count Cumulative Skip to Item
65 to 135 Range of Values 2346 2346
. Missing 563 2909

GTXDRANK - Amount of glucose challenge drank

Variable Name:
GTXDRANK
SAS Label:
Amount of glucose challenge drank
English Text:
Amount of glucose challenge drank
Target:
Both males and females 12 YEARS - 150 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 All 2381 2381
2 Some 9 2390
3 None 124 2514
. Missing 395 2909

PHAFSTHR - Total length of 'food fast', hours

Variable Name:
PHAFSTHR
SAS Label:
Total length of 'food fast', hours
English Text:
Total length of 'food fast', hours
Target:
Both males and females 12 YEARS - 150 YEARS
Code or Value Value Description Count Cumulative Skip to Item
8 to 23 Range of Values 2909 2909
. Missing 0 2909

PHAFSTMN - Total length of 'food fast', minutes

Variable Name:
PHAFSTMN
SAS Label:
Total length of 'food fast', minutes
English Text:
Total length of 'food fast', minutes
Target:
Both males and females 12 YEARS - 150 YEARS
Code or Value Value Description Count Cumulative Skip to Item
0 to 59 Range of Values 2909 2909
. Missing 0 2909

GTDCODE - Incomplete OGTT Comment Code

Variable Name:
GTDCODE
SAS Label:
Incomplete OGTT Comment Code
English Text:
Incomplete OGTT Comment Code
Target:
Both males and females 12 YEARS - 150 YEARS
Code or Value Value Description Count Cumulative Skip to Item
0 OGTT complete 2345 2345
20 Hemophiliac 0 2345
21 Cancer chemotherapy within 4 weeks 0 2345
22 Diabetic on medications 266 2611
23 Refused venipuncture 0 2611
24 Ill/faint during test 5 2616
25 Venipuncture unsuccessful 11 2627
26 Currently pregnant 1 2628
27 Refused glucose challenge 59 2687
28 Fasting less than 9 hours 7 2694
29 Came late/left early 38 2732
30 Other 177 2909
. Missing 0 2909