Validation of the Hyperinsulinemic-Euglycemic Clamp Technique

• Research type

  Research Study

• Full title

  Validation of the Hyperinsulinemic-Euglycemic Clamp Technique

• IRAS ID

  92698

• Contact name

  Joseph Chiesa

• Sponsor organisation

  Covance

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Insulin resistance is a condition in which the natural hormone insulin becomes less effective at lowering blood glucose levels. Certain types of cells in the body, such as fat and muscle cells, require insulin to stimulate the uptake of glucose. In subjects with insulin resistance, these cells fail to respond adequately to circulating insulin by failing to take up glucose which results in high blood glucose levels. Additionally, insulin resistance in liver cells results in failure to suppress glucose production and release into the blood and failure to convert glucose to glycogen for storage. With the expanding epidemiological significance of insulin resistance conditions such as Type 2 Diabetes and obesity, the assessment of insulin sensitivity has become of significant value to metabolic research. The hyperinsulinemic-euglycemic clamp is a commonly conducted investigational procedure and is considered to be the ??gold standard? or the method of choice to measure insulin resistance due to the fact that the results obtained can be interpreted simply. During the hyperinsulinemic-euglycemic clamp technique the subject??s blood insulin level will be increased artificially using a constant intravenous infusion of insulin. The blood glucose levels will be monitored frequently using a bedside glucose analyser and the subject will be given replacement glucose (20% dextrose) via intravenous infusion in order to ??clamp? or keep the blood glucose levels at a predetermined normal level. Assuming that the constant intravenous infusion of insulin will be sufficient to suppress glucose production by the liver, the glucose infusion rate will be equal to the rate of glucose uptake by the fat and muscle cells. The rate of the glucose infusion will therefore give an idea about the degree of insulin resistance. Up to 40 healthy volunteers will be participating in this study. There will be 2 parts to the study with up to 20 subjects in each part. Part 1 will be a 120 min (2 hour) hyperinsulinemic-euglycemic clamp. Part 2 will be a 360 min (6 hour) hyperinsulinemic-euglycemic clamp.Participation in the study is expected to last up to approximately 1 month from the time of screening to the study visit.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/SC/0503

• Date of REC Opinion

  20 Dec 2011

• REC opinion

  Favourable Opinion