Back to resultsOral Glucose Stimulation in Normal-weight and Obese Volunteers
Primary Purpose
Endocrine System Diseases
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Placebo
Glucose 25g
Glucose 10g
Sponsored by
About this trial
This is an interventional prevention trial for Endocrine System Diseases focused on measuring glucagon-like peptide-1, peptide tyrosine tyrosine, ghrelin, stomach, small intestine, gastric emptying
Eligibility 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
Sites / Locations
- University Hospital Basel
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Glucose 10g
Glucose 25g
Placebo
Arm Description
10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)via nasogastric tube
25g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)via nasogastric tube
intragastric tap water
Outcomes
Primary Outcome Measures
Effect of different oral glucose loads on secretion of satiation hormones
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
measured by C13 breath test
Full Information
NCT ID
NCT01875575
First Posted
May 8, 2013
Last Updated
June 11, 2013
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT01875575
Brief Title
Oral Glucose Stimulation in Normal-weight and Obese Volunteers
Official Title
Oral Glucose in Normal-weight and Obese Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocrine System Diseases
Keywords
glucagon-like peptide-1, peptide tyrosine tyrosine, ghrelin, stomach, small intestine, gastric emptying
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glucose 10g
Arm Type
Active Comparator
Arm Description
10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)via nasogastric tube
Arm Title
Glucose 25g
Arm Type
Active Comparator
Arm Description
25g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)via nasogastric tube
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
intragastric tap water
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucose 25g
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucose 10g
Primary Outcome Measure Information:
Title
Effect of different oral glucose loads on secretion of satiation hormones
Description
Plasma concentrations of glucose, insulin, glucagon, ghrelin, GLP-1, PYY and CCK are measured
Time Frame
240min.
Secondary Outcome Measure Information:
Title
Effect of different oral glucose loads on gastric emptying
Description
measured by C13 breath test
Time Frame
240min.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Beglinger, Prof
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
26942445
Citation
Meyer-Gerspach AC, Cajacob L, Riva D, Herzog R, Drewe J, Beglinger C, Wolnerhanssen BK. Mechanisms Regulating Insulin Response to Intragastric Glucose in Lean and Non-Diabetic Obese Subjects: A Randomized, Double-Blind, Parallel-Group Trial. PLoS One. 2016 Mar 4;11(3):e0150803. doi: 10.1371/journal.pone.0150803. eCollection 2016.
Results Reference
derived
Learn more about this trial
Oral Glucose Stimulation in Normal-weight and Obese Volunteers
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