Oral Glucose Stimulation in Normal-weight and Obese Volunteers

June 11, 2013 updated by: University Hospital, Basel, Switzerland

Oral Glucose in Normal-weight and Obese Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, CH-4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
240min.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of different oral glucose loads on gastric emptying
Time Frame: 240min.
measured by C13 breath test
240min.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

May 8, 2013

First Submitted That Met QC Criteria

June 11, 2013

First Posted (ESTIMATE)

June 12, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 12, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKBB 08/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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