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Oral Glucose Stimulation in Normal-weight and Obese Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01875575
First Posted: June 12, 2013
Last Update Posted: June 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
  Purpose
The objective of this study is to examine gastric emptying and satiety hormones after oral glucose stimulation in 2 different concentrations in normal-weight and obese patients.

Condition Intervention
Endocrine System Diseases Dietary Supplement: Placebo Dietary Supplement: Glucose 25g Dietary Supplement: Glucose 10g

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Oral Glucose in Normal-weight and Obese Volunteers

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Effect of different oral glucose loads on secretion of satiation hormones [ Time Frame: 240min. ]
    Plasma concentrations of glucose, insulin, glucagon, ghrelin, GLP-1, PYY and CCK are measured


Secondary Outcome Measures:
  • Effect of different oral glucose loads on gastric emptying [ Time Frame: 240min. ]
    measured by C13 breath test


Enrollment: 24
Study Start Date: February 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Glucose 10g
10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)via nasogastric tube
Dietary Supplement: Glucose 10g
Active Comparator: Glucose 25g
25g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)via nasogastric tube
Dietary Supplement: Glucose 25g
Placebo Comparator: Placebo
intragastric tap water
Dietary Supplement: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy normal weight subjects with a body-mass index of 19.0-24.5 or healthy obese subjects with a body-mass index of > 30
  • Normal eating habits
  • Age 18-40 years
  • Stable body weight for at least three months

Exclusion Criteria:

  • Smoking
  • Substance abuse
  • Regular intake of medications (except for oral contraceptives)
  • Medical or psychiatric illness
  • Any abnormality detected during the screening procedure
  • history of gastrointestinal disorders
  • food allergies
  Contacts and Locations
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): NCT01875575


Locations
Switzerland
University Hospital Basel
Basel, Switzerland, CH-4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Christoph Beglinger, Prof University Hospital, Basel, Switzerland
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01875575     History of Changes
Other Study ID Numbers: EKBB 08/11
First Submitted: May 8, 2013
First Posted: June 12, 2013
Last Update Posted: June 12, 2013
Last Verified: June 2013

Keywords provided by University Hospital, Basel, Switzerland:
glucagon-like peptide-1
peptide tyrosine tyrosine
ghrelin
stomach
small intestine
gastric emptying

Additional relevant MeSH terms:
Endocrine System Diseases