NCT02902224

Brief Summary

The objective is to investigate neuro-anatomical correlates of the regulation of energy intake by means of functional MRI before and after bariatric surgery. Administration of glucose as well as fructose is followed by functional brain MRI, and findings are correlated with serum glucagon-like peptide 1 (GLP-1) levels as an endogenous satiety signal in obese humans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration 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

April 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

2.3 years

First QC Date

September 12, 2016

Last Update Submit

September 12, 2016

Conditions

Exploratory Behavior

Outcome Measures

Primary Outcomes (1)

  • Functional magnetic resonance imaging (fMRI) in healthy, obese volunteers while they performed a working memory task: changes in cerebral blood flow

    changes from baseline to one hour after treatment

Secondary Outcomes (3)

  • Changes in plasma glucose

    Changes from baseline to one hour after treatment

  • Changes in plasma insulin

    Changes from baseline to one hour after treatment

  • Changes in Plasma GLP-1

    Changes from baseline to one hour after treatment

Study Arms (3)

PLACEBO

PLACEBO COMPARATOR

Single intragastric instillation of 300ml tap water via nasogastric tube

Dietary Supplement: Tap water

GLUCOSE

ACTIVE COMPARATOR

Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube

Dietary Supplement: Glucose

FRUCTOSE

ACTIVE COMPARATOR

Single intragastric instillation of 25g Fructose in 300ml tap water via nasogastric tube

Dietary Supplement: Fructose

Interventions

Tap waterDIETARY_SUPPLEMENT

300ml tap water via nasogastric tube

PLACEBO
GlucoseDIETARY_SUPPLEMENT

300ml tap water with 75g glucose via nasogastric tube

GLUCOSE
FructoseDIETARY_SUPPLEMENT

300ml tap water with 25g fructose via nasogastric tube

FRUCTOSE

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • right-handed
  • morbidly obese patients
  • scheduled for bariatric surgery

You may not qualify if:

  • Diabetes mellitus
  • cardiovascular disease
  • neurologic or psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Switzerland

Location

MeSH Terms

Conditions

Exploratory Behavior

Interventions

GlucoseFructose

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Christoph Beglinger, Prof

    University of Basel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 15, 2016

Study Start

April 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 15, 2016

Record last verified: 2016-09

Locations

CH(1)