Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005889
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-06-02
Brief Title:
Gluconeogenesis in Very Low Birth Weight Infants Who Are Receiving Nutrition By Intravenous Infusion
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
Study of Gluconeogenesis in Very Low Birth Weight Infants Receiving Total Parenteral Nutrition
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Very low birth weight infants have problems maintaining normal blood sugar levels Gluconeogenesis is the production of sugar from amino acids and fats The best combination of amino acids fat and sugar to help very low birth weigh infants maintain normal blood sugar levels is not yet known
PURPOSE Clinical trial to study how very low birth weight infants break down amino acids fat and sugar given by intravenous infusion and the effect of different combinations of nutrients on the infants ability to maintain normal blood sugar levels
PURPOSE Clinical trial to study how very low birth weight infants break down amino acids fat and sugar given by intravenous infusion and the effect of different combinations of nutrients on the infants ability to maintain normal blood sugar levels
Detailed Description:
PROTOCOL OUTLINE Patients are assigned to one of 6 study groups
Patients receive infusions of stable isotope tracers 15Nurea IV beginning at -12 hours and continuing over 22 hours to measure protein oxidation U-13Cglucose IV beginning at zero hour and continuing over 10 hours to measure glucose appearance rate and gluconeogenesis 2-13Cglycerol IV over 10 hours to measure lipolysis and 1-Cleucine IV over 10 hours to measure proteolysis Blood samples are obtained before the start of the urea tracer infusion before the start of the glucose glycerol and leucine tracer infusions and at study hours 4 45 5 9 95 and 10 Blood glucose is measured hourly and patients receive glucose IV if blood glucose falls below 40 mgdL
Group I Patients are randomized to one of two study arms Arm I Patients receive standard total parenteral nutrition TPN except the U-13Cglucose is substituted for a portion of the glucose Arm II The infusions of lipids Intralipid and amino acids TrophAmine are discontinued at study hour zero The infusion rate of natural glucose will be reduced during the first hour and thereafter discontinued
Group II Patients are randomized to receive either TrophAmine or Intralipid IV over the last 5 hours of the study
Group III Patients are randomized to receive one of two different doses of glycerol IV over the last 5 hours of the study
Group IV Patients are randomized to receive either glutamine or alanine IV over the last 5 hours of the study
Group V Patients receive glucagon IV for 24 hours prior to study Patients are then randomized to receive glucagon IV with either IV glucose alone or with Intralipid and TrophAmine IV
Group VI Patients who are hyperglycemic receive TPN and U-13Cglucose as in group I arm I over 14 hours and regular insulin IV at 10 hours followed by an IV infusion of carbohydrate Blood samples obtained between hours 4 and 5 are omitted and are drawn instead between hours 13 and 14
Patients receive infusions of stable isotope tracers 15Nurea IV beginning at -12 hours and continuing over 22 hours to measure protein oxidation U-13Cglucose IV beginning at zero hour and continuing over 10 hours to measure glucose appearance rate and gluconeogenesis 2-13Cglycerol IV over 10 hours to measure lipolysis and 1-Cleucine IV over 10 hours to measure proteolysis Blood samples are obtained before the start of the urea tracer infusion before the start of the glucose glycerol and leucine tracer infusions and at study hours 4 45 5 9 95 and 10 Blood glucose is measured hourly and patients receive glucose IV if blood glucose falls below 40 mgdL
Group I Patients are randomized to one of two study arms Arm I Patients receive standard total parenteral nutrition TPN except the U-13Cglucose is substituted for a portion of the glucose Arm II The infusions of lipids Intralipid and amino acids TrophAmine are discontinued at study hour zero The infusion rate of natural glucose will be reduced during the first hour and thereafter discontinued
Group II Patients are randomized to receive either TrophAmine or Intralipid IV over the last 5 hours of the study
Group III Patients are randomized to receive one of two different doses of glycerol IV over the last 5 hours of the study
Group IV Patients are randomized to receive either glutamine or alanine IV over the last 5 hours of the study
Group V Patients receive glucagon IV for 24 hours prior to study Patients are then randomized to receive glucagon IV with either IV glucose alone or with Intralipid and TrophAmine IV
Group VI Patients who are hyperglycemic receive TPN and U-13Cglucose as in group I arm I over 14 hours and regular insulin IV at 10 hours followed by an IV infusion of carbohydrate Blood samples obtained between hours 4 and 5 are omitted and are drawn instead between hours 13 and 14
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BCM-GCRC-0667 | None | None | None |
| BCM-H7213 | None | None | None |