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Gluconeogenesis in Very Low Birth Weight Infants Who Are Receiving Nutrition By Intravenous Infusion

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was:  Recruiting
Baylor College of Medicine
Information provided by:
National Center for Research Resources (NCRR) Identifier:
First received: June 2, 2000
Last updated: June 23, 2005
Last verified: December 2003

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 Intervention
Infant, Low Birth Weight
Drug: alanine
Drug: amino acids
Drug: glucagon
Drug: glucose
Drug: glutamine
Drug: glycerol
Drug: insulin
Drug: leucine
Drug: lipids
Drug: urea

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Study of Gluconeogenesis in Very Low Birth Weight Infants Receiving Total Parenteral Nutrition

Resource links provided by NLM:

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 96
Study Start Date: October 1999
Detailed Description:

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.


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00005889

United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Agneta L. Sunehag    713-798-6725   
Sponsors and Collaborators
National Center for Research Resources (NCRR)
Baylor College of Medicine
Study Chair: Agneta L. Sunehag Baylor College of Medicine
  More Information Identifier: NCT00005889     History of Changes
Other Study ID Numbers: NCRR-M01RR00188-0667
Study First Received: June 2, 2000
Last Updated: June 23, 2005

Keywords provided by National Center for Research Resources (NCRR):
endocrine disorders
low birth weight
neonatal disorders
rare disease

Additional relevant MeSH terms:
Body Weight
Birth Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cryoprotective Agents
Protective Agents processed this record on May 25, 2017