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Trial record 61 of 70 for:    ORLISTAT

The Effect of Different Macronutrients on Gastrointestinal Hormone Secretion After Gastric Bypass Operation

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ClinicalTrials.gov Identifier: NCT02372526
Recruitment Status : Unknown
Verified February 2017 by Kirstine Nyvold Bojsen-Moeller, Hvidovre University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : February 26, 2015
Last Update Posted : February 7, 2017
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Kirstine Nyvold Bojsen-Moeller, Hvidovre University Hospital

Brief Summary:
The purpose of this study is to determine the type of macronutrient (carbohydrate, lipid or protein) that most potently stimulates the endogen secretion of different gut hormones (primary outcome = Glucagon-Like peptide-1) in gastric bypass operated patients. The study also includes a comparison of the secretion of gut hormones after oral intake of lipid with or without a pancreatic lipase inhibitor.

Condition or disease Intervention/treatment
Bariatric Surgery (Gastric Bypass) Overweight Other: Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutes Other: Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutes Other: Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes Other: Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes

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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Effect of Different Macronutrients on Gastrointestinal Hormone Secretion After Gastric Bypass Operation
Study Start Date : January 2015
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Group/Cohort Intervention/treatment
10 Roux-en-Y gastric bypass patients
Isocaloric amounts of specific macronutrients is mixed with 4 g vegetable bouillon and tested against each others ability to induce GLP-1 secretion. The mealtest takes place at 4 different days with 3-14 days separation.
Other: Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutes
Other Name: LACPRODAN SP-9225 INSTANT Whey Protein Isolate

Other: Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutes
Other Name: Lurpak® smør(butter) 81% fat

Other: Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes
Other Name: Urtegaarden Druesukker (Dextrose monohydrat)

Other: Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes
Other Name: Lurpak® smør(butter) 81% fat with 120 mg Xenical® Orlistat

10 Healthy Control subjects
Isocaloric amounts of specific macronutrients is mixed with 4 g vegetable bouillon and tested against each others ability to induce GLP-1 secretion. The mealtest takes place at 4 different days with 3-14 days separation.
Other: Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutes
Other Name: LACPRODAN SP-9225 INSTANT Whey Protein Isolate

Other: Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutes
Other Name: Lurpak® smør(butter) 81% fat

Other: Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes
Other Name: Urtegaarden Druesukker (Dextrose monohydrat)

Other: Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes
Other Name: Lurpak® smør(butter) 81% fat with 120 mg Xenical® Orlistat




Primary Outcome Measures :
  1. Within group difference in Glucagon-like Peptide 1 secretion (evaluated by iAUC). [ Time Frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240 ]
    I.e. Comparison of GLP-1 secretion (iAUC) as a result of intake of different macronutrients between a) gastric bypass patients only b) healthy volunteers only.


Secondary Outcome Measures :
  1. Within group difference in Glucagon secretion (evaluated by iAUC). [ Time Frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240 ]
  2. Within group difference in Glucose-dependent insulinotropic peptide secretion (evaluated by iAUC). [ Time Frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240 ]
  3. Within group difference in Cholecystokinin secretion (evaluated by iAUC). [ Time Frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240 ]
  4. Within group difference in Peptide YY 3-36 secretion (evaluated by iAUC). [ Time Frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240 ]
  5. Within group difference in Ghrelin secretion (evaluated by iAUC). [ Time Frame: 0, 30, 45, 60, 120, 180, 240 ]
  6. Within group difference in Changes in bile acids. [ Time Frame: 0, 30, 45, 60, 120, 180, 240 ]
  7. Within group difference in Changes in glycerol, triacylglycerol and free fatty acids. [ Time Frame: 0, 30, 45, 60, 120, 180, 240 ]
  8. Within group difference in Insulin secretion (evaluated by iAUC). [ Time Frame: 2xBasline, 0, 10, 15, 20, 30, 40, 45, 60, 90, 120, 180, 240 ]
  9. Within group difference in Plasma glucose concentration. [ Time Frame: 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240 ]
  10. Within group difference in Visual Analog Scale. [ Time Frame: 0, 30, 60, 90, 120, 180, 240 ]
    Hunger, satiety, abdominal pain and nausea measured by standard 10 cm Visual Analog Scale

  11. Within group difference in Ad libitum food intake (grams). [ Time Frame: 240 ]
  12. Within group difference in Heart rate (bpm). [ Time Frame: 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240 ]
  13. Within group difference in Blood pressure (mmhg). [ Time Frame: 0, 15, 30, 45, 60, 90, 120, 180, 240 ]

Other Outcome Measures:
  1. Between groups difference in Glucagon-like Peptide 1 secretion (evaluated by iAUC). [ Time Frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240 ]
    I.e. Comparison of GLP-1 secretion (iAUC) as a result of intake of different macronutrients between Gastric bypass operated patients and Healthy volunteers.

  2. Between groups difference in Glucagon secretion (evaluated by iAUC). [ Time Frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240 ]
  3. Between groups difference in Glucose-dependent insulinotropic peptide secretion (evaluated by iAUC). [ Time Frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240 ]
  4. Between groups difference in Cholecystokinin secretion (evaluated by iAUC). [ Time Frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240 ]
  5. Between groups difference in Peptide YY 3-36 secretion (evaluated by iAUC). [ Time Frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240 ]
  6. Between groups difference in Ghrelin secretion (evaluated by iAUC). [ Time Frame: 0, 30, 45, 60, 120, 180, 240 ]
  7. Between groups difference in Changes in bile acids. [ Time Frame: 0, 30, 45, 60, 120, 180, 240 ]
  8. Between groups difference in Changes in glycerol, triacylglycerol and free fatty acids. [ Time Frame: 0, 30, 45, 60, 120, 180, 240 ]
  9. Between groups difference in Insulin secretion (evaluated by iAUC). [ Time Frame: 2xBasline, 0, 10, 15, 20, 30, 40, 45, 60, 90, 120, 180, 240 ]
  10. Between groups difference in Plasma glucose concentration. [ Time Frame: 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240 ]
  11. Between groups difference in Visual Analog Scale. [ Time Frame: 0, 30, 60, 90, 120, 180, 240 ]
    Hunger, satiety, abdominal pain and nausea measured by standard 10 cm Visual Analog Scale

  12. Between groups difference in Ad libitum food intake (grams). [ Time Frame: 240 ]
  13. Between groups difference in Heart rate (bpm). [ Time Frame: 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240 ]
  14. Between groups difference in Blood pressure (mmhg). [ Time Frame: 0, 15, 30, 45, 60, 90, 120, 180, 240 ]

Biospecimen Retention:   Samples Without DNA
Plasma and serum.


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
RYGB Patients who have underwent RYGB surgery more than 18 months earlier, weight stabile (+/- 5 kg during 1 month). Healthy control subjects who have not underwent bariatric surgery.
Criteria

RYGB Patients:

Inclusion Criteria:

  • Underwent RYGB surgery more than 18 months earlier, weight stabile (+/- 5 kg during 1 month)

Exclusion Criteria:

  • Inadequate thyroid substitution, undergoing treatment with drugs known to interact with Orlistat (such as cyclosporine, anticoagulating agents, amiodarone, amlodipine and epileptics), where pausing the treatment with these is not an option. Type 1 or 2 diabetes mellitus now or prior to RYGB operation. Serious heart or respiratory illness. Haemoglobin levels below 6,5 mM.

Healthy control subjects:

Inclusion Criteria:

  • Have not underwent bariatric surgery.

Exclusion Criteria:

  • Inadequate thyroid substitution, undergoing treatment with drugs known to interact with Orlistat (such as cyclosporine, anticoagulating agents, amiodarone, amlodipine and epileptics), where pausing the treatment with these is not an option. Type 1 or 2 diabetes mellitus now or prior. Serious heart or respiratory illness. Haemoglobin levels below 6,5 mM.

Information from the National Library of Medicine

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): NCT02372526


Locations
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Denmark
Endocrinology Research Center, Hvidovre University Hospital
Hvidovre, Copenhagen, Denmark, 2650
Sponsors and Collaborators
Kirstine Nyvold Bojsen-Moeller
University of Copenhagen

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Responsible Party: Kirstine Nyvold Bojsen-Moeller, Postdoc, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02372526     History of Changes
Other Study ID Numbers: CZJ-MA-14
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Keywords provided by Kirstine Nyvold Bojsen-Moeller, Hvidovre University Hospital:
Glucagon-like Peptide-1
Glucose-dependent insulinotropic peptide
Glucagon
Peptide YY 3-36
Ghrelin
Body Weight
Obesity
Overnutrition
Overweight
Gastrointestinal Agents
GLP-1 secretagogue
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms
Glucagon
Hormones
Nutrients
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents
Growth Substances