Growth hormone, glutamine, and an optimal diet reduces parenteral nutrition in patients with short bowel syndrome: A prospective, randomized, placebo-controlled, double-blind clinical trial

Theresa A. Byrne, Douglas W. Wilmore, Kishore Iyer, John Dibaise, Kerri Clancy, Malcolm K. Robinson, Peter Chang, Joseph M. Gertner, David Lautz

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Abstract

Objective: To determine if growth hormone (GH) and glutamine (Gln) might allow for a reduction in parenteral nutrition (PN) in individuals with short bowel syndrome. Background Data: Following massive intestinal resection, patients frequently sustain severe nutrient malabsorption and are dependent on PN for life. GH treatment with or without GIn might allow for a reduction in PN. Methods: A prospective, double-blind, randomized, placebo-controlled clinical trial performed in 41 adults dependent on PN. Following screening, patients were admitted to an in-house facility for 6 weeks. After 2 weeks of stabilization and dietary optimization, patients were randomized to one of 3 treatment arms (1:2:2 ratio): oral Gln (30 g/day) + GH placebo (control group, n = 9), Gln placebo + GH (0.1 mg/kg per day, n = 16), or GIn + GH (n = 16). Standard criteria based on clinical and laboratory measurements were followed to determine PN volume and content. After 4 weeks of treatment, patients were discharged and monitored; GH and GH placebo were discontinued, but the diet with Gln or Gln placebo was continued for 3 months. Results: Patients receiving GH + GIn placebo + diet showed greater reductions in PN volume (5.9 ± 3.8 L/wk, mean ± SD), PN calories (4338 ± 1858 calories/wk), and PN infusions (3 ± 2 infusions/wk) than corresponding reductions in the Gln + diet group (3.8 ± 2.4 L/wk; 2633 ± 1341 calories/wk; 2 ± 1 infusions/wk, P < 0.05). Patients who received GH + Gln + diet showed the greatest reductions (7.7 ± 3.2 L/wk; 5751 ± 2082 calories/wk; 4 ± 1 infusions/wk, P < 0.001 versus Gln + diet). At the 3-month follow-up, only patients who had received GH + Gln + diet maintained significant reductions in PN (P < 0.005) compared with the Gln + diet. Conclusions: Treatment with GH + diet or GH + Gln + diet initially permitted significantly more weaning from PN than Gln + diet. Only subjects receiving GH + Gln + diet maintained this effect for at least 3 months.

Original languageEnglish (US)
Pages (from-to)655-661
Number of pages7
JournalAnnals of Surgery
Volume242
Issue number5
DOIs
StatePublished - Nov 2005
Externally publishedYes

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Short Bowel Syndrome
Parenteral Nutrition
Glutamine
Growth Hormone
Placebos
Clinical Trials
Diet
Parenteral Infusions
Therapeutics
Weaning

ASJC Scopus subject areas

  • Surgery

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Growth hormone, glutamine, and an optimal diet reduces parenteral nutrition in patients with short bowel syndrome : A prospective, randomized, placebo-controlled, double-blind clinical trial. / Byrne, Theresa A.; Wilmore, Douglas W.; Iyer, Kishore; Dibaise, John; Clancy, Kerri; Robinson, Malcolm K.; Chang, Peter; Gertner, Joseph M.; Lautz, David.

In: Annals of Surgery, Vol. 242, No. 5, 11.2005, p. 655-661.

Research output: Contribution to journalArticle

Byrne, Theresa A. ; Wilmore, Douglas W. ; Iyer, Kishore ; Dibaise, John ; Clancy, Kerri ; Robinson, Malcolm K. ; Chang, Peter ; Gertner, Joseph M. ; Lautz, David. / Growth hormone, glutamine, and an optimal diet reduces parenteral nutrition in patients with short bowel syndrome : A prospective, randomized, placebo-controlled, double-blind clinical trial. In: Annals of Surgery. 2005 ; Vol. 242, No. 5. pp. 655-661.
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abstract = "Objective: To determine if growth hormone (GH) and glutamine (Gln) might allow for a reduction in parenteral nutrition (PN) in individuals with short bowel syndrome. Background Data: Following massive intestinal resection, patients frequently sustain severe nutrient malabsorption and are dependent on PN for life. GH treatment with or without GIn might allow for a reduction in PN. Methods: A prospective, double-blind, randomized, placebo-controlled clinical trial performed in 41 adults dependent on PN. Following screening, patients were admitted to an in-house facility for 6 weeks. After 2 weeks of stabilization and dietary optimization, patients were randomized to one of 3 treatment arms (1:2:2 ratio): oral Gln (30 g/day) + GH placebo (control group, n = 9), Gln placebo + GH (0.1 mg/kg per day, n = 16), or GIn + GH (n = 16). Standard criteria based on clinical and laboratory measurements were followed to determine PN volume and content. After 4 weeks of treatment, patients were discharged and monitored; GH and GH placebo were discontinued, but the diet with Gln or Gln placebo was continued for 3 months. Results: Patients receiving GH + GIn placebo + diet showed greater reductions in PN volume (5.9 ± 3.8 L/wk, mean ± SD), PN calories (4338 ± 1858 calories/wk), and PN infusions (3 ± 2 infusions/wk) than corresponding reductions in the Gln + diet group (3.8 ± 2.4 L/wk; 2633 ± 1341 calories/wk; 2 ± 1 infusions/wk, P < 0.05). Patients who received GH + Gln + diet showed the greatest reductions (7.7 ± 3.2 L/wk; 5751 ± 2082 calories/wk; 4 ± 1 infusions/wk, P < 0.001 versus Gln + diet). At the 3-month follow-up, only patients who had received GH + Gln + diet maintained significant reductions in PN (P < 0.005) compared with the Gln + diet. Conclusions: Treatment with GH + diet or GH + Gln + diet initially permitted significantly more weaning from PN than Gln + diet. Only subjects receiving GH + Gln + diet maintained this effect for at least 3 months.",
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T1 - Growth hormone, glutamine, and an optimal diet reduces parenteral nutrition in patients with short bowel syndrome

T2 - A prospective, randomized, placebo-controlled, double-blind clinical trial

AU - Byrne, Theresa A.

AU - Wilmore, Douglas W.

AU - Iyer, Kishore

AU - Dibaise, John

AU - Clancy, Kerri

AU - Robinson, Malcolm K.

AU - Chang, Peter

AU - Gertner, Joseph M.

AU - Lautz, David

PY - 2005/11

Y1 - 2005/11

N2 - Objective: To determine if growth hormone (GH) and glutamine (Gln) might allow for a reduction in parenteral nutrition (PN) in individuals with short bowel syndrome. Background Data: Following massive intestinal resection, patients frequently sustain severe nutrient malabsorption and are dependent on PN for life. GH treatment with or without GIn might allow for a reduction in PN. Methods: A prospective, double-blind, randomized, placebo-controlled clinical trial performed in 41 adults dependent on PN. Following screening, patients were admitted to an in-house facility for 6 weeks. After 2 weeks of stabilization and dietary optimization, patients were randomized to one of 3 treatment arms (1:2:2 ratio): oral Gln (30 g/day) + GH placebo (control group, n = 9), Gln placebo + GH (0.1 mg/kg per day, n = 16), or GIn + GH (n = 16). Standard criteria based on clinical and laboratory measurements were followed to determine PN volume and content. After 4 weeks of treatment, patients were discharged and monitored; GH and GH placebo were discontinued, but the diet with Gln or Gln placebo was continued for 3 months. Results: Patients receiving GH + GIn placebo + diet showed greater reductions in PN volume (5.9 ± 3.8 L/wk, mean ± SD), PN calories (4338 ± 1858 calories/wk), and PN infusions (3 ± 2 infusions/wk) than corresponding reductions in the Gln + diet group (3.8 ± 2.4 L/wk; 2633 ± 1341 calories/wk; 2 ± 1 infusions/wk, P < 0.05). Patients who received GH + Gln + diet showed the greatest reductions (7.7 ± 3.2 L/wk; 5751 ± 2082 calories/wk; 4 ± 1 infusions/wk, P < 0.001 versus Gln + diet). At the 3-month follow-up, only patients who had received GH + Gln + diet maintained significant reductions in PN (P < 0.005) compared with the Gln + diet. Conclusions: Treatment with GH + diet or GH + Gln + diet initially permitted significantly more weaning from PN than Gln + diet. Only subjects receiving GH + Gln + diet maintained this effect for at least 3 months.

AB - Objective: To determine if growth hormone (GH) and glutamine (Gln) might allow for a reduction in parenteral nutrition (PN) in individuals with short bowel syndrome. Background Data: Following massive intestinal resection, patients frequently sustain severe nutrient malabsorption and are dependent on PN for life. GH treatment with or without GIn might allow for a reduction in PN. Methods: A prospective, double-blind, randomized, placebo-controlled clinical trial performed in 41 adults dependent on PN. Following screening, patients were admitted to an in-house facility for 6 weeks. After 2 weeks of stabilization and dietary optimization, patients were randomized to one of 3 treatment arms (1:2:2 ratio): oral Gln (30 g/day) + GH placebo (control group, n = 9), Gln placebo + GH (0.1 mg/kg per day, n = 16), or GIn + GH (n = 16). Standard criteria based on clinical and laboratory measurements were followed to determine PN volume and content. After 4 weeks of treatment, patients were discharged and monitored; GH and GH placebo were discontinued, but the diet with Gln or Gln placebo was continued for 3 months. Results: Patients receiving GH + GIn placebo + diet showed greater reductions in PN volume (5.9 ± 3.8 L/wk, mean ± SD), PN calories (4338 ± 1858 calories/wk), and PN infusions (3 ± 2 infusions/wk) than corresponding reductions in the Gln + diet group (3.8 ± 2.4 L/wk; 2633 ± 1341 calories/wk; 2 ± 1 infusions/wk, P < 0.05). Patients who received GH + Gln + diet showed the greatest reductions (7.7 ± 3.2 L/wk; 5751 ± 2082 calories/wk; 4 ± 1 infusions/wk, P < 0.001 versus Gln + diet). At the 3-month follow-up, only patients who had received GH + Gln + diet maintained significant reductions in PN (P < 0.005) compared with the Gln + diet. Conclusions: Treatment with GH + diet or GH + Gln + diet initially permitted significantly more weaning from PN than Gln + diet. Only subjects receiving GH + Gln + diet maintained this effect for at least 3 months.

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