ObesityNCT01851616
Oral Glucosestimulation After Gastric Bypass Surgery
A study testing 25g of glucose in 200ml tap water, given orally (plus 50 mg 13C-sodium acetate) and 10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate) in people with Obesity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- 25g of glucose in 200ml tap water, given orally (plus 50 mg 13C-sodium acetate) and 10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2013to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 6 weeks post gastric bypass surgery,
- non-diabetic patient
Who cannot join
- smoker,
- diabetes,
- gastrointestinal motility disorder,
- medication influencing gastric emptying
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
After gastric bypass many patients suffer from early and/or late dumping syndrome as a reaction to carbohydrate rich meals. Gastric emptying after bypass is accelerated and nutrition enters the intestine faster, which leads to osmotically driven fluid shifts from the blood to the lumen. Late dumping occurs 1-3 h after eating, and is caused by hyperinsulinemia and is therefore characterized by symptoms of hypoglycemia like weakness, sweating, and dizziness. Many people have both types. In most studies examining satiety hormones after oral glucose stimulation in non-operated patients, glucose loads of 50-75g are used. For a measurable GLP-1 rise a threshold of 2 kcal/min. at the intestine is needed. After gastric bypass gastric emptying is accelerated and less glucose is necessary to reach this threshold. The "threshold load" and "tolerable load without dumping symptoms" is not yet know.
- Conditions
- Obesity
- Being tested
- 25g of glucose in 200ml tap water, given orally (plus 50 mg 13C-sodium acetate), 10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)
- Keywords
- glucose, blood
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25g of 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)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Glucose 25g | Active comparator | 25g of glucose in 200ml tap water, given orally (plus 50 mg 13C-sodium acetate) Receives: 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) Receives: Dietary Supplement: 10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of oral glucose leading to increase in satiety hormones
Measured: 240 min.
Secondary outcomes (1)
Amount of oral glucose leading to clinical signs of dumping
Measured: 240min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Beglinger, Prof., Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851616
- Sponsor's protocol ID
- EKBB 298/12/1
- Status last verified
- May 2013
- First submitted
- 8 May 2013
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Glucosestimulation After Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT01851616
- Acronym / sponsor ID
- EKBB 298/12/1
- Conditions
- Obesity
- Keywords
- glucose, blood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 10 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After gastric bypass many patients suffer from early and/or late dumping syndrome as a reaction to carbohydrate rich meals. Gastric emptying after bypass is accelerated and nutrition enters the intestine faster, which leads to osmotically driven fluid shifts from the blood to the lumen. Late dumping occurs 1-3 h after eating, and is caused by hyperinsulinemia and is therefore characterized by symptoms of hypoglycemia like weakness, sweating, and dizziness. Many people have both types. In most studies examining satiety hormones after oral glucose stimulation in non-operated patients, glucose loads of 50-75g are used. For a measurable GLP-1 rise a threshold of 2 kcal/min. at the intestine is needed. After gastric bypass gastric emptying is accelerated and less glucose is necessary to reach this threshold. The "threshold load" and "tolerable load without dumping symptoms" is not yet know.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucose 25g | Active comparator | Dietary Supplement: 25g of glucose in 200ml tap water, given orally (plus 50 mg 13C-sodium acetate)25g of glucose in 200ml tap water, given orally (plus 50 mg 13C-sodium acetate) |
| Glucose 10g | Active comparator | Dietary Supplement: 10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 6 weeks post gastric bypass surgery,
- non-diabetic patient
Key exclusion criteria (4 listed)
- smoker,
- diabetes,
- gastrointestinal motility disorder,
- medication influencing gastric emptying
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
amount of oral glucose leading to increase in satiety hormones
Time frame: 240 min.
1 secondary outcome
Amount of oral glucose leading to clinical signs of dumping
Time frame: 240min.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Beglinger, Prof. principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 25g of glucose in 200ml tap water, given orally (plus 50 mg 13C-sodium acetate) and 10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate) in people with Obesity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of oral glucose leading to increase in satiety hormones (time frame: 240 min.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2013.