NCT01851616

Brief Summary

The objective of this study is to examine gastric emptying and satiety hormones after oral glucose stimulation in 2 different concentrations in morbidly obese patients after Roux-en-Y-gastric-Bypass.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable obesity

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

January 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 month 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
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
Last Updated

May 10, 2013

Status Verified

May 1, 2013

Enrollment Period

2 months

First QC Date

May 8, 2013

Last Update Submit

May 9, 2013

Conditions

Obesity

Keywords

glucose, blood

Outcome Measures

Primary Outcomes (1)

  • amount of oral glucose leading to increase in satiety hormones

    240 min.

Secondary Outcomes (1)

  • Amount of oral glucose leading to clinical signs of dumping

    240min.

Other Outcomes (1)

  • Gastric emptying after gastric bypass

    240min

Study Arms (2)

Glucose 25g

ACTIVE COMPARATOR

25g of glucose in 200ml tap water, given orally (plus 50 mg 13C-sodium acetate)

Dietary Supplement: 25g of glucose in 200ml tap water, given orally (plus 50 mg 13C-sodium acetate)

Glucose 10g

ACTIVE COMPARATOR

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

Dietary Supplement: 10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)

Interventions

25g of glucose in 200ml tap water, given orally (plus 50 mg 13C-sodium acetate)DIETARY_SUPPLEMENT
Glucose 25g
10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)DIETARY_SUPPLEMENT
Glucose 10g

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • weeks post gastric bypass surgery,
  • non-diabetic patient

You may not qualify if:

  • smoker,
  • diabetes,
  • gastrointestinal motility disorder,
  • medication influencing gastric emptying

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Basel

Basel, CH-4031, Switzerland

Location

MeSH Terms

Conditions

Obesity

Interventions

Glucose

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Christoph Beglinger, Prof.

    University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2013

First Posted

May 10, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2013

Study Completion

April 1, 2013

Last Updated

May 10, 2013

Record last verified: 2013-05

Locations

CH(1)