• Component Description
• Eligible Sample
• Description of Laboratory Methodology
• Laboratory Method Files
• Data Processing and Editing
• Laboratory Quality Assurance and Monitoring
• Analytic Notes
• Codebook
  • SEQN - Respondent sequence number
  • WTSAF2YR - Fasting Subsample 2 Year MEC Weight
  • LBXGLU - Fasting Glucose (mg/dL)
  • LBDGLUSI - Fasting Glucose (mmol/L)
  • LBXIN - Insulin (uU/mL)
  • LBDINSI - Insulin (pmol/L)
  • PHAFSTHR - Total length of 'food fast', hours
  • PHAFSTMN - Total length of 'food fast', minutes

National Health and Nutrition Examination Survey

2009-2010 Data Documentation, Codebook, and Frequencies

Plasma Fasting Glucose & Insulin (GLU_F)

Data File: GLU_F.xpt

First Published: January 2012

Last Revised: NA

Component Description

Diabetes mellitus was assessed by measures of fasting plasma glucose, two-hour glucose (OGTT) and serum insulin in participants aged 12 years and over in the morning (AM) examination session only. Glycohemoglobin measures are also available for a full sample.

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. The prevalence of diabetes and overweight (one of the major risk factors for diabetes) continue to increase. Substantial new efforts to prevent or control diabetes have begun, including the Diabetes Prevention Trial and the National Diabetes Education Program.

Eligible Sample

Participants aged 12 years and older who were examined in the morning session were tested.

Description of Laboratory Methodology

Blood specimens were processed, stored and shipped to Fairview Medical Center Laboratory at the University of Minnesota, Minneapolis Minnesota for analysis.

Glucose
In this enzymatic method glucose is converted to glucose-6-phosphate (G-6-P) by hexokinase in the presence of ATP, a phosphate donor. Glucose-6-phosphate dehydrogenase then converts the G-6-P to gluconate-6-P in the presence of NADP+. As the NADP+ is reduced to NADPH during this reaction, the resulting increase in absorbance at 340 nm (secondary wavelength = 700 nm) is measured. This is an endpoint reaction that is specific for glucose.

Insulin
Insulin is the primary hormone responsible for controlling glucose metabolism, and its secretion is determined by plasma glucose concentration. The insulin molecule is synthesized in the pancreas as pro-insulin and is later cleaved to form C-peptide and insulin. The principal function of insulin is to control the uptake and utilization of glucose in the peripheral tissues. Insulin concentrations are severely reduced in insulin-dependent diabetes mellitus (IDDM) and some other conditions, while insulin concentrations are raised in non-insulin-dependent diabetes mellitus (NIDDM), obesity, and some endocrine disorders.

The Merocodia Insulin ELISA is a two-site enzyme immunoassay utilizing the direct sandwich technique with two monoclonal antibodies directed against separate antigenic determinants of the insulin molecule. Specimen, control, or standard is pipetted into the sample well, and then followed by the addition of peroxidase-conjugated anti-insulin antibodies. Insulin present in the sample will bind to anti-insulin antibodies bound to the sample well, while the peroxidase-conjugated anti-insulin antibodies will also bind to the insulin at the same time. After washing to remove unbound enzyme-labelled antibodies, a labelled substrate is added and binds to the conjugated antibodies. Acid is added to the sample well to stop the reaction, and the colorimetric endpoint is read on a microplate spectrophotometer set to the appropriate light wavelength.
 

An oral glucose tolerance test (OGTT) continued. A fasting glucose blood test was performed on all participants 12 years and older, who were examined in the morning session after a 9 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 Trutol^TM.

There are seven exclusion criteria, including hemophilia and chemotherapy safety exclusions, fasting < 9 hours, taking insulin or oral medications for diabetes, refusing phlebotomy, and not drinking all the entire Trutol solution within the allotted time.

There were no changes (from the previous 2 years of NHANES) to equipment, lab methods, or lab site.

Detailed instructions on specimen collection and processing can be found in the NHANES Laboratory/Medical Technologists Procedures Manual (LPM).

Laboratory Method Files

Insulin - Elecsys 2010 Immunoassay (Updated August 2016)

Insulin - Mercodia ELISA (August 2016)

Data Processing and Editing

Read the General Documentation on Laboratory Data file for detailed data processing and editing protocols.

Two calculated variables were created in this data file. The formula for their creation is as follows:

LBXGLU and LBDGLUSI:
The fasting glucose value in mg/dL (LBXGLU) was converted to mmol/L (LBDGLUSI) by multiplying by 0.05551 (rounded to 3 decimals).

LBXIN and LBDINSI:
The insulin value in µU/mL (LBXIN) was converted to pmol/L (LBDINSI) by multiplying by 6.0 (rounded to 2 decimals). 
 

Laboratory Quality Assurance and Monitoring

The NHANES quality control and quality assurance protocols (QA/QC) meet the 1988 Clinical Laboratory Improvement Act mandates. Detailed QA/QC instructions are discussed in the NHANES Laboratory/Medical Technologists Procedures Manual (LPM). Read the General Documentation on Laboratory Data file for detailed QA/QC protocols.

Analytic Notes

Change in methods for serum insulin

In 2009-2010, there was a change in methods for serum insulin. The insulin was performed 2005-2009 using the Mercodia sandwich ELISA assay and was switched in late 2009 to a Roche chemiluminescent immunoassay performed on the Elecsys 2010 analyzer. A crossover study of 346 specimens was performed between the two methods and the Mercodia insulin values had a higher mean and median compared to the Roche assay by approximately 7%. This was also seen in the sample participants when comparing Mercodia to Roche insulin values. Using a fractional polynomial regression, the 2010 insulin participant results were increased to compare to the 2009 insulin results.

Reporting Glucose Results

The Minnesota Laboratory Data File (GLU_F) (which contains laboratory test results for glucose - LBXGLU) was measured using the reference analytic method. However, the Iowa laboratory (BIOPRO_F), that measures biochemistry profiles, also included measurements of serum glucose. The serum glucose values (LBXSGL) reported in the Iowa lab should not be used to determine undiagnosed diabetes or prediabetes. Instead, plasma glucose values from the Minnesota Lab (LBXGLU) should be for data analysis.

NHANES Survey Design:

The analysis of NHANES laboratory data must be conducted with the key survey design and basic demographic variables. The Demographic file contains: Status Variables providing core information on the survey participant including examination status, Recoded Demographic Variables including age, gender, race etc., and Interview and Examination Sample Weight Variables and Survey Design Variables. The Questionnaire Data Files contain socio-economic data, health indicators, and other related information collected during household interviews. The Phlebotomy Examination file includes auxiliary information on duration of fasting, the time of day of the venipuncture, and the conditions precluding venipuncture. The Demographic, Questionnaire and Phlebotomy Examination files may be linked to the laboratory data file using the unique survey participant identifier SEQN.

Sampling Weights

The analyst is strongly encouraged to use the fasting sampling weights in this file to analyze 2009–2010 glucose and insulin levels.

There will be two weight files 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 OGTT weights and data are in a separate file (OGTT_F).

Exam sample weights should be used for analyses. 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.

Codebook and Frequencies