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Protocol - Fasting Plasma Glucose - Blood Draw

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Protocol Name from Source:

[link[www.phenxtoolkit.org/toolkit_content/supplemental_info/diabetes/additional_info/NHANES_OGTT.pdf|2007-2008 National Health and Nutrition Examination Survey (NHANES) Oral Glucose Tolerance Test Manual]]

Availability:

Publicly available

Description:

Participants are asked to fast for at least 9 hours (generally overnight) prior to the fasting plasma glucose test. Participants are asked a series of exclusionary questions and then have blood drawn. The plasma is separated from the blood via centrifugation and glucose concentration is determined via a hexokinase-mediated reaction.

Protocol:

The following is a summary version of the full National Health and Nutrition Examination Survey 2007-2008 protocol.

The full National Health and Nutrition Examination Survey 2007-2008 Fasting Plasma Glucose Test Procedures are part of the Oral Glucose Tolerance Test Procedure and can be found here: [link[www.phenxtoolkit.org/toolkit_content/supplemental_info/diabetes/additional_info/NHANES_OGTT.pdf|2007-2008 NHANES Oral Glucose Tolerance Test Manual]].

Exclusion Criteria:

Persons will be excluded from this component if they:

• Report that they are taking oral medications for diabetes;

• Report that they are taking insulin;

• Report that they are pregnant;

• Report that they have hemophilia;

• Report that they have received cancer chemotherapy in the last 3 weeks; and

• Report that they have not fasted at least 9 hours.

SP = Sample Person.

1. Did you eat or drink anything other than plain water after [Insert time at 9 hours prior to sample collection] last night?

[ ] Yes

[ ] No

[ ] Refused

[ ] Don’t Know

If answer is "No," then he or she has met the 9-hour fast. If answer is "Yes," "Don’t know," or "Refused," then the actual fasting time is unknown.

Confirmation Question:

2. Have you had any of the following since {insert time from 1 here}?

Coffee or tea with cream and sugar? [Include milk or non-dairy creamers.]

[ ] Yes If Yes, record time and date _____________

[ ] No

Alcohol, such as beer, wine, or liquor?

[ ] Yes If Yes, record time and date _____________

[ ] No

Gum, breath mints, lozenges, or cough drops, or other cough or cold remedies?

[ ] Yes If Yes, record time and date _____________

[ ] No

Antacids, laxatives, or anti-diarrheals?

[ ] Yes If Yes, record time and date _____________

[ ] No

Dietary Supplements such as vitamins and minerals? [Include multivitamins and single nutrient supplements.]

[ ] Yes If Yes, record time and date _____________

[ ] No

3. Are you currently pregnant?

1 [ ] Yes

2 [ ] No

3 [ ] Don’t Know

If answer is "Yes," then the SP is blocked from the Fasting Plasma Glucose test. If answer is "No" or "Don’t Know," the SP completes Fasting Plasma Glucose test.

4. {Is SP/Are you} now taking insulin?

1 [ ] Yes

2 [ ] No

7 [ ] Refused

9 [ ] Don’t Know

If the SP answers, "Yes," the SP is excluded from the Fasting Plasma Glucose test. If answer is "No" or "Don’t Know," the SP completes Fasting Plasma Glucose test.

5. {Is SP/Are you} now taking diabetic pills to lower {{his/her}/your} blood sugar? These are sometimes called oral agents or oral hypoglycemic agents

1 [ ] Yes

2 [ ] No

7 [ ] Refused

9 [ ] Don’t Know

If the SP answers, "Yes," the SP is excluded from the Fasting Plasma Glucose test. If SP answer "No" or "Don’t Know," the SP completes Fasting Plasma Glucose test.

6. Do you have hemophilia? (exclusion from Phlebotomy)

1 [ ] Yes

2 [ ] No

7 [ ] Refused

9 [ ] Don’t Know

If the SP answers, "Yes," the SP is excluded from the Fasting Plasma Glucose test. If SP answer "No" or "Don’t Know," the SP completes Fasting Plasma Glucose test.

7. Have you received cancer chemotherapy in the past four weeks or do you anticipate such therapy in the next 4 weeks? (exclusion from Phlebotomy)

1 [ ] Yes

2 [ ] No

7 [ ] Refused

9 [ ] Don’t Know

If the SP answers, "Yes," the SP is excluded from the Fasting Plasma Glucose test. If SP answer "No" or "Don’t Know," the SP completes Fasting Plasma Glucose test.

Venipuncture

Venipuncture should generally be performed using the median cubital, cephalic, or basilic veins in the left arm unless this arm is unsuitable. If the veins in the left arm are unsuitable, look for suitable veins on the right arm. If the veins in the antecubital space on both arms are not suitable, then look for veins in the forearm or dorsal side of the hand on the left arm/hand and then the right arm/hand.

Editor’s Note: Please review chapter 4 of the Laboratory Procedures Manual from the National Health and Nutrition Examination Survey 2007-2008 for a full description of Phlebotomy procedures: [link[www.phenxtoolkit.org/toolkit_content/supplemental_info/diabetes/additional_info/NHANES_Lab_Manual.pdf|2007-2008 NHANES Lab Manual]].

Recording the Results of the Venipuncture Procedure

Immediately after completing the venipuncture, record the results of the blood draw, the reasons for a tube not being drawn according to the protocol, and any comments about the venipuncture.

Process the Sample for the Fasting Plasma Glucose Test

Editor’s Note: Please review chapter 8 of the Laboratory Procedures Manual from the National Health and Nutrition Examination Survey 2007-2008 for a full description of Blood Processing procedures: [link[www.phenxtoolkit.org/toolkit_content/supplemental_info/diabetes/additional_info/NHANES_Lab_Manual.pdf|2007-2008 NHANES Lab Manual]].

Centrifuge and separate the plasma from the 10 mL tube as soon as possible. Process the specimen even if the contents of the tube clot.

• Separate the plasma by centrifugation.

• Use a calibrated plastic transfer pipette to transfer at least 0.5 mL plasma.

• Determine if the plasma is hemolyzed, turbid, lipemic, or icteric. If so, enter a comment to describe the plasma.

• Close all vessels secured to prevent leakage and evaporation.

Lab Assay for Fasting Plasma Glucose

The Diabetes Working Group recommends that glucose concentration be determined according to a hexokinase-mediated reaction such as the one developed by the University of Minnesota for use in the National Health and Nutrition Examination Survey: [link[www.phenxtoolkit.org/toolkit_content/supplemental_info/diabetes/additional_info/Fasting_Glucose_Lab_Assay.pdf|2007-2008 NHANES Fasting Glucose Lab Assay]].

Reference Ranges:

Fasting plasma glucose concentration normally ranges between 60-100 mg/dL Non-fasting glucose concentration normally ranges between 60-139 mg/dL

Personnel and Training Required

Phlebotomist Medical Technologist Laboratory which can perform hexokinase-mediated reaction

Equipment Needs

Phlebotomy supplies

Requirements

Requirement CategoryRequired
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentNo
Specialized requirements for biospecimen collectionNo
Specialized trainingNo

Mode of Administration

Self-administered

Life Stage:

Child, Adolescent, Adult, Senior

Specific Instructions:

If the 9-hour fast is not met, the Diabetes Working Group (WG) recommends that the test can still be completed as a "casual" glucose concentration (see the Oral Glucose Tolerance Test Manual for casual glucose reference ranges for screening plus/minus diabetes). The Diabetes WG refers users to the Fasting Plasma Proinsulin assay in Diabetes Supplemental Information to obtain more information about insulin resistance.

Note from the Diabetes WG: Rather than asking if the subject had anything to eat or drink after 11:30, the WG notes that is acceptable to record the current time and the time when the subject last had anything other than plain water.

Note from the Diabetes WG: The investigator should record the reason(s) a sample person is excluded from the fasting plasma glucose test.

Note from the Diabetes WG: The Diabetes WG recommends that the investigator record whether the blood was drawn and whether the full amount was obtained.

Note from the Diabetes WG: Blood should be collected in an appropriate 10 mL EDTA tube. Invert the tube 3 to 4 times to mix, store on ice, and centrifuge within 30 minutes. Processing should yield ~4.5 mL of plasma that can then be separated into several 0.5 mL aliquots for multiple different tests.

Note from the Diabetes WG: Plasma should be stored at -80°C until testing and shipped on dry ice to prevent thawing.

Note from the Diabetes WG: To aid comparability, the Diabetes WG recommends that the investigator record the make and manufacturer of equipment used and the repeatability and coefficients of variation for the assay.

Note from the Expert Review Panel (ERP): Plasma or Serum

Collection of blood samples for the measurement of analytes requires a general determination of whether to use serum or plasma for the assay and also a determination of the type of collection tube to be obtained. For example, if plasma is to be used, a determination needs to be made as to whether EDTA- or heparin-containing collection tubes are used. While comparable values are obtained for many analytes from either serum or plasma, there may be situations where differences are more pronounced, and serum- or plasma-specific norms will be needed for references. The protocol presented here uses EDTA plasma. At times, it may be possible to collect both, but other considerations such as participant burden may be the deciding factor. It is important to match assay type with sample type. Some automated devices may preclude the use of EDTA plasma, for example, while others may be optimized for it. Investigators should choose methods of collection that match the methods of analysis. This will best be done by communicating with the laboratory where the proposed assays will be performed. They will become an important partner with you in assuring that there is compatibility from collection to assays to interpretation and reporting of levels and results.

Note from the ERP: This protocol may be used for participants under age 12, as appropriate, given the need to fast.

Research Domain Information

Release Date:

October 1, 2015

Definition

A bioassay to determine the concentration of plasma glucose after a period of fasting.

Purpose

According to the American Diabetes Association (ADA, 2014a), the Fasting Plasma Glucose assay is the preferred method to screen for prediabetes and diabetes. When compared to other methods to screen for diabetes, such as the Oral Glucose Tolerance Test (OGTT) and Glycosylated Hemoglobin (HbA1c) test, the Fasting Plasma Glucose test is cheaper, easier to implement, and lower burden to participants.

Selection Rationale

The National Health and Nutrition Examination Survey 2007-2008 protocol was selected as the best practice methodology and most widely used protocol to measure fasting plasma glucose concentration.

Language

English, Spanish

Standards

StandardNameIDSource
Common Data Elements (CDE)Person Fasting Plasma Glucose Assay Concentration Value3070691CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)Fast plasma gluc blood draw proto62851-1LOINC

Process and Review

The [link[phenx.org/node/62|Expert Review Panel #1]] reviewed the measures in the Anthropometrics, Diabetes, Physical Activity and Physical Fitness, and Nutrition and Dietary Supplements domains.

Guidance from the ERP includes:

• Changed name of measure

• Added recommendations on use of serum or plasma

Back-compatible: no changes to Data Dictionary

Previous version in Toolkit archive ([link[www.phenxtoolkit.org/index.php?pageLink=browse.archive.protocols&id=140000|link]])

Source

Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS). (2002). National Health and Nutrition Examination Survey Questionnaire. Shared Exclusion Questions for the MEC Examination. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Questions 6 and 7.

Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS). (2005-06). National Health and Nutrition Examination Survey Questionnaire. Oral Glucose Tolerance Test (OGTT) Procedures Manual. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.

Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS). (2007-08). National Health and Nutrition Examination Survey Questionnaire. Laboratory Procedures Manual. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.

General References

American Diabetes Association (ADA). (2014a). Diagnosis and classification of diabetes mellitus. Diabetes Care, 37(Suppl. 1), S81-S90.

American Diabetes Association (ADA). (2014b). Standards of medical care in diabetes-2014. Diabetes Care, 37(Suppl. 1), S14-S80.

Frank, E. A., Shubha, M. C., & D’Souza, C. J. M. (2012). Blood glucose determination: Plasma or serum? Journal of Clinical Laboratory Analysis, 26, 317-320.

Miles, R. R., Roberts, R. F., Putnam, A. R., & Roberts, W. L. (2004). Comparison of serum and heparinized plasma samples for measurement of chemistry analytes [Letter to the Editor]. Clinical Chemistry, 50(9), 1704-1705.

Protocol ID:

140801

Variables:

Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX140801_Glucose_ConcentrationPX140801140000Glucose concentration4Variable Mapping
PX140801_Fasting_Or_Casual_Glucose_ConcentrationPX140801150000Was the participant fasting?4Variable Mapping
PX140801_Coefficient_Of_VariationPX140801130000Coefficient of variation for the assay4N/A
PX140801_Eat_Or_DrinkPX140801010000Did you eat or drink anything other than plain water after 11:30 last night?4N/A
PX140801_Last_Eat_Or_Drink_DatePX140801010100When did you last eat or drink anything other than plain water?4Variable Mapping
PX140801_Last_Eat_Or_Drink_TimePX140801010200When did you last eat or drink anything other than plain?4Variable Mapping
PX140801_Coffee_TeaPX140801020100Have you had any of the following since {insert time from 1 here}? Coffee or tea with cream and sugar? [Include milk or non-dairy creamers.]4Variable Mapping
PX140801_Coffee_Tea_TimePX140801020101If Yes, record time4N/A
PX140801_Coffee_Tea_DatePX140801020102If Yes, record Date4N/A
PX140801_AlcoholPX140801020201Have you had any of the following since {insert time from 1 here}? Alcohol, such as beer, wine, or liquor?4N/A
PX140801_Alcohol_TimePX140801020202If Yes, record time4N/A
PX140801_Alcohol_DatePX140801020203If Yes, record date4N/A
PX140801_GumPX140801020301Have you had any of the following since {insert time from 1 here}? Gum, breath mints, lozenges, or cough drops, or other cough or cold remedies?4N/A
PX140801_Gum_TimePX140801020302If Yes, record time4N/A
PX140801_Gum_DatePX140801020303If Yes, record date4N/A
PX140801_AntacidsPX140801020401Have you had any of the following since {insert time from 1 here}? Antacids, laxatives, or anti-diarrheals?4N/A
PX140801_Antacids_TimePX140801020402If Yes, record time4N/A
PX140801_Antacids_DatePX140801020403If Yes, record date4N/A
PX140801_Dietary_SupplementsPX140801020501Have you had any of the following since {insert time from 1 here}? Dietary Supplements such as vitamins and minerals? [Include multivitamins and single nutrient supplements.]4N/A
PX140801_Dietary_Supplements_TimePX140801020502If Yes, record time4N/A
PX140801_Dietary_Supplements_DatePX140801020503If Yes, record date4N/A
PX140801_PregnantPX140801030000Are you currently pregnant?4Variable Mapping
PX140801_Taking_InsulinPX140801040000{Is SP/Are you} now taking insulin?4Variable Mapping
PX140801_Diabetic_PillsPX140801050000{Is SP/Are you} now taking diabetic pills to lower {his/her}/your} blood sugar? These are sometimes called oral agents or oral hypoglycemic agents4Variable Mapping
PX140801_HemophiliaPX140801060000Do you have hemophilia? (exclusion from Phlebotomy)4Variable Mapping
PX140801_ChemotherapyPX140801070000Have you received cancer chemotherapy in the past four weeks or do you anticipate such therapy in the next four weeks? (exclusion from Phlebotomy)4N/A
PX140801_Exclusion_CriteriaPX140801080000Exclusion Criteria4N/A
PX140801_Blood_Draw_DonePX140801090000Was blood drawn?4Variable Mapping
PX140801_Blood_Draw_SamplePX140801090100Was full sample obtained?4Variable Mapping
PX140801_Blood_Draw_CommentsPX140801090200Record any comments about the blood draw, including any reasons for the tube not being drawn according to the protocol.4Variable Mapping
PX140801_Sample_CommentsPX140801100000Record any comments about the sample during processing.4Variable Mapping
PX140801_Equipment_MakePX140801110100Make of the equipment used to perform the hexokinase-mediated reaction.4N/A
PX140801_Equipment_ManufacturerPX140801110200Manufacturer of the equipment used to perform the hexokinase-mediated reaction.4N/A
PX140801_Assay_RepeatabilityPX140801120000Repeatability of the assay4N/A