NCT01875575

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
Last Updated

June 12, 2013

Status Verified

June 1, 2013

Enrollment Period

2 months

First QC Date

May 8, 2013

Last Update Submit

June 11, 2013

Conditions

Keywords

glucagon-like peptide-1peptide tyrosine tyrosineghrelinstomachsmall intestinegastric emptying

Outcome Measures

Primary Outcomes (1)

  • 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

    240min.

Secondary Outcomes (1)

  • Effect of different oral glucose loads on gastric emptying

    240min.

Study Arms (3)

Glucose 10g

ACTIVE COMPARATOR

10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)via nasogastric tube

Dietary Supplement: Glucose 10g

Glucose 25g

ACTIVE COMPARATOR

25g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)via nasogastric tube

Dietary Supplement: Glucose 25g

Placebo

PLACEBO COMPARATOR

intragastric tap water

Dietary Supplement: Placebo

Interventions

PlaceboDIETARY_SUPPLEMENT
Placebo
Glucose 25gDIETARY_SUPPLEMENT
Glucose 25g
Glucose 10gDIETARY_SUPPLEMENT
Glucose 10g

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, CH-4031, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Endocrine System Diseases

Interventions

Glucose

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Christoph Beglinger, Prof

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2013

First Posted

June 12, 2013

Study Start

February 1, 2013

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

June 12, 2013

Record last verified: 2013-06

Locations