Gluconeogenesis in Very Low Birth Weight Infants Who Are Receiving Nutrition By Intravenous Infusion
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| ClinicalTrials.gov Identifier: NCT00005889 |
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Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was: Recruiting
First Posted : June 5, 2000
Last Update Posted : June 24, 2005
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infant, Low Birth Weight Hyperglycemia | Drug: alanine Drug: amino acids Drug: glucagon Drug: glucose Drug: glutamine Drug: glycerol Drug: insulin Drug: leucine Drug: lipids Drug: urea | Not Applicable |
PROTOCOL OUTLINE: Patients are assigned to one of 6 study groups.
Patients receive infusions of stable isotope tracers: [15N]urea IV beginning at -12 hours and continuing over 22 hours to measure protein oxidation; [U-13C]glucose IV beginning at zero hour and continuing over 10 hours to measure glucose appearance rate and gluconeogenesis; [2-13C]glycerol IV over 10 hours to measure lipolysis; and [1-C]leucine 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, 4.5, 5, 9, 9.5, and 10. Blood glucose is measured hourly, and patients receive glucose IV if blood glucose falls below 40 mg/dL.
Group I: Patients are randomized to one of two study arms. Arm I: Patients receive standard total parenteral nutrition (TPN), except the [U-13C]glucose 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-13C]glucose 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 Type : | Interventional (Clinical Trial) |
| Enrollment : | 96 participants |
| Primary Purpose: | Treatment |
| Official Title: | Study of Gluconeogenesis in Very Low Birth Weight Infants Receiving Total Parenteral Nutrition |
| Study Start Date : | October 1999 |
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| Ages Eligible for Study: | up to 6 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
- Clinically stable, very low birth weight infants (750-1,500 grams)
- Normal blood glucose values OR Blood glucose greater than 175 mg/dL
- No prior insulin
- No sepsis Oxygen supply less than 30% Normal acid base status
- No malformation
- No discernible diseases
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005889
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Agneta L. Sunehag 713-798-6725 asunehag@bcm.tmc.edu | |
| Study Chair: | Agneta L. Sunehag | Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00005889 History of Changes |
| Other Study ID Numbers: |
NCRR-M01RR00188-0667 BCM-H7213 BCM-GCRC-0667 |
| First Posted: | June 5, 2000 Key Record Dates |
| Last Update Posted: | June 24, 2005 |
| Last Verified: | December 2003 |
Keywords provided by National Center for Research Resources (NCRR):
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endocrine disorders hyperglycemia low birth weight neonatal disorders rare disease |
Additional relevant MeSH terms:
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Body Weight Hyperglycemia Birth Weight Signs and Symptoms Glucose Metabolism Disorders Metabolic Diseases Glucagon |
Glycerol Gastrointestinal Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cryoprotective Agents Protective Agents |