Bariatric Surgery (Gastric Bypass)NCT02372526
The Effect of Different Macronutrients on Gastrointestinal Hormone Secretion After Gastric Bypass Operation
An observational study of Bariatric Surgery (Gastric Bypass) and Overweight, run by Kirstine Nyvold Bojsen-Moeller at 1 site in Denmark.
Trial summary
The purpose of this study is to determine the type of macronutrient (carbohydrate, lipid or protein) that most potently stimulates the endogen secretion of different gut hormones (primary outcome = Glucagon-Like peptide-1) in gastric bypass operated patients. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery (Gastric Bypass), Overweight
- What is being tested?
- Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutes, Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutes and Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to Jun 2017
- Phase
- Observational
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: RYGB Patients who have underwent RYGB surgery more than 18 months earlier, weight stabile (+/- 5 kg during 1 month). Healthy control subjects who have not underwent bariatric surgery.
Who may be able to join
- Underwent RYGB surgery more than 18 months earlier, weight stabile (+/- 5 kg during 1 month)
- Have not underwent bariatric surgery.
Who cannot join
- Inadequate thyroid substitution, undergoing treatment with drugs known to interact with Orlistat (such as cyclosporine, anticoagulating agents, amiodarone, amlodipine and epileptics), where pausing the treatment with these is not an option. Type 1 or 2 diabetes mellitus now or prior to RYGB operation. Serious heart or respiratory illness. Haemoglobin levels below 6,5 mM.
- Healthy control subjects:
- Inadequate thyroid substitution, undergoing treatment with drugs known to interact with Orlistat (such as cyclosporine, anticoagulating agents, amiodarone, amlodipine and epileptics), where pausing the treatment with these is not an option. Type 1 or 2 diabetes mellitus now or prior. Serious heart or respiratory illness. Haemoglobin levels below 6,5 mM.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Endocrinology Research Center, Hvidovre University Hospital
Hvidovre, Copenhagen, 2650
About this study
The purpose of this study is to determine the type of macronutrient (carbohydrate, lipid or protein) that most potently stimulates the endogen secretion of different gut hormones (primary outcome = Glucagon-Like peptide-1) in gastric bypass operated patients. The study also includes a comparison of the secretion of gut hormones after oral intake of lipid with or without a pancreatic lipase inhibitor.
- Conditions
- Bariatric Surgery (Gastric Bypass), Overweight
- Being tested
- Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutes, Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutes, Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes, Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes
- Keywords
- Glucagon-like Peptide-1, Glucose-dependent insulinotropic peptide, Glucagon, Peptide YY 3-36, Ghrelin, Body Weight, Obesity, Overnutrition, Overweight, Gastrointestinal Agents, GLP-1 secretagogue
- Medical subject headings
- Overweight, Body Weight, Obesity, Overnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutesOther
Also called LACPRODAN SP-9225 INSTANT Whey Protein Isolate
Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutesOther
Also called Lurpak® smør(butter) 81% fat
Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutesOther
Also called Urtegaarden Druesukker (Dextrose monohydrat)
Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutesOther
Also called Lurpak® smør(butter) 81% fat with 120 mg Xenical® Orlistat
| Study group | Role | What they receive |
|---|---|---|
| 10 Roux-en-Y gastric bypass patients | Isocaloric amounts of specific macronutrients is mixed with 4 g vegetable bouillon and tested against each others ability to induce GLP-1 secretion. The mealtest takes place at 4 different days with 3-14 days separation. Receives: Other: Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutes; Other: Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutes; Other: Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes; Other: Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes | |
| 10 Healthy Control subjects | Isocaloric amounts of specific macronutrients is mixed with 4 g vegetable bouillon and tested against each others ability to induce GLP-1 secretion. The mealtest takes place at 4 different days with 3-14 days separation. Receives: Other: Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutes; Other: Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutes; Other: Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes; Other: Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within group difference in Glucagon-like Peptide 1 secretion (evaluated by iAUC).
I.e. Comparison of GLP-1 secretion (iAUC) as a result of intake of different macronutrients between a) gastric bypass patients only b) healthy volunteers only.
Measured: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Secondary outcomes (13)
Within group difference in Glucagon secretion (evaluated by iAUC).
Measured: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Within group difference in Glucose-dependent insulinotropic peptide secretion (evaluated by iAUC).
Measured: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Within group difference in Cholecystokinin secretion (evaluated by iAUC).
Measured: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Within group difference in Peptide YY 3-36 secretion (evaluated by iAUC).
Measured: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Within group difference in Ghrelin secretion (evaluated by iAUC).
Measured: 0, 30, 45, 60, 120, 180, 240
Within group difference in Changes in bile acids.
Measured: 0, 30, 45, 60, 120, 180, 240
Within group difference in Changes in glycerol, triacylglycerol and free fatty acids.
Measured: 0, 30, 45, 60, 120, 180, 240
Within group difference in Insulin secretion (evaluated by iAUC).
Measured: 2xBasline, 0, 10, 15, 20, 30, 40, 45, 60, 90, 120, 180, 240
Within group difference in Plasma glucose concentration.
Measured: 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240
Within group difference in Visual Analog Scale.
Hunger, satiety, abdominal pain and nausea measured by standard 10 cm Visual Analog Scale
Measured: 0, 30, 60, 90, 120, 180, 240
Within group difference in Ad libitum food intake (grams).
Measured: 240
Within group difference in Heart rate (bpm).
Measured: 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240
Within group difference in Blood pressure (mmhg).
Measured: 0, 15, 30, 45, 60, 90, 120, 180, 240
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2016
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery (Gastric Bypass)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirstine Nyvold Bojsen-Moeller
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor-investigator, Kirstine Nyvold Bojsen-Moeller, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372526
- Sponsor's protocol ID
- CZJ-MA-14
- Status last verified
- Feb 2017
- First submitted
- 20 Feb 2015
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Macronutrients on Gastrointestinal Hormone Secretion After Gastric Bypass Operation
- ClinicalTrials.gov ID
- NCT02372526
- Acronym / sponsor ID
- CZJ-MA-14
- Conditions
- Bariatric Surgery (Gastric Bypass), Overweight
- Keywords
- Glucagon-like Peptide-1, Glucose-dependent insulinotropic peptide, Glucagon, Peptide YY 3-36, Ghrelin, Body Weight, Obesity, Overnutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Kirstine Nyvold Bojsen-MoellerUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jan 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 26 Feb 2015 (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 purpose of this study is to determine the type of macronutrient (carbohydrate, lipid or protein) that most potently stimulates the endogen secretion of different gut hormones (primary outcome = Glucagon-Like peptide-1) in gastric bypass operated patients. The study also includes a comparison of the secretion of gut hormones after oral intake of lipid with or without a pancreatic lipase inhibitor.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 Roux-en-Y gastric bypass patients | – | Other: Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutes, Other: Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutes, Other: Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes, Other: Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutesIsocaloric amounts of specific macronutrients is mixed with 4 g vegetable bouillon and tested against each others ability to induce GLP-1 secretion. The mealtest takes place at 4 different days with 3-14 days separation. |
| 10 Healthy Control subjects | – | Other: Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutes, Other: Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutes, Other: Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes, Other: Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutesIsocaloric amounts of specific macronutrients is mixed with 4 g vegetable bouillon and tested against each others ability to induce GLP-1 secretion. The mealtest takes place at 4 different days with 3-14 days separation. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- RYGB Patients who have underwent RYGB surgery more than 18 months earlier, weight stabile (+/- 5 kg during 1 month). Healthy control subjects who have not underwent bariatric surgery.
Key inclusion criteria (2 listed)
- Underwent RYGB surgery more than 18 months earlier, weight stabile (+/- 5 kg during 1 month)
- Have not underwent bariatric surgery.
Key exclusion criteria (3 listed)
- Inadequate thyroid substitution, undergoing treatment with drugs known to interact with Orlistat (such as cyclosporine, anticoagulating agents, amiodarone, amlodipine and epileptics), where pausing the treatment with these is not an option. Type 1 or 2 diabetes mellitus now or prior to RYGB operation. Serious heart or respiratory illness. Haemoglobin levels below 6,5 mM.
- Inadequate thyroid substitution, undergoing treatment with drugs known to interact with Orlistat (such as cyclosporine, anticoagulating agents, amiodarone, amlodipine and epileptics), where pausing the treatment with these is not an option. Type 1 or 2 diabetes mellitus now or prior. Serious heart or respiratory illness. Haemoglobin levels below 6,5 mM.
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 |
|---|---|---|
| Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutesAlso: LACPRODAN SP-9225 INSTANT Whey Protein Isolate | Other | 10 Healthy Control subjects, 10 Roux-en-Y gastric bypass patients |
| Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutesAlso: Lurpak® smør(butter) 81% fat | Other | 10 Healthy Control subjects, 10 Roux-en-Y gastric bypass patients |
| Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutesAlso: Urtegaarden Druesukker (Dextrose monohydrat) | Other | 10 Healthy Control subjects, 10 Roux-en-Y gastric bypass patients |
| Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutesAlso: Lurpak® smør(butter) 81% fat with 120 mg Xenical® Orlistat | Other | 10 Healthy Control subjects, 10 Roux-en-Y gastric bypass patients |
Primary outcome
Within group difference in Glucagon-like Peptide 1 secretion (evaluated by iAUC).
Time frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
I.e. Comparison of GLP-1 secretion (iAUC) as a result of intake of different macronutrients between a) gastric bypass patients only b) healthy volunteers only.
13 secondary outcomes
Within group difference in Glucagon secretion (evaluated by iAUC).
Time frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Within group difference in Glucose-dependent insulinotropic peptide secretion (evaluated by iAUC).
Time frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Within group difference in Cholecystokinin secretion (evaluated by iAUC).
Time frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Within group difference in Peptide YY 3-36 secretion (evaluated by iAUC).
Time frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Within group difference in Ghrelin secretion (evaluated by iAUC).
Time frame: 0, 30, 45, 60, 120, 180, 240
Within group difference in Changes in bile acids.
Time frame: 0, 30, 45, 60, 120, 180, 240
Within group difference in Changes in glycerol, triacylglycerol and free fatty acids.
Time frame: 0, 30, 45, 60, 120, 180, 240
Within group difference in Insulin secretion (evaluated by iAUC).
Time frame: 2xBasline, 0, 10, 15, 20, 30, 40, 45, 60, 90, 120, 180, 240
Within group difference in Plasma glucose concentration.
Time frame: 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240
Within group difference in Visual Analog Scale.
Time frame: 0, 30, 60, 90, 120, 180, 240
Within group difference in Ad libitum food intake (grams).
Time frame: 240
Within group difference in Heart rate (bpm).
Time frame: 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240
Within group difference in Blood pressure (mmhg).
Time frame: 0, 15, 30, 45, 60, 90, 120, 180, 240
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery (Gastric Bypass) and Overweight, run by Kirstine Nyvold Bojsen-Moeller at 1 site in Denmark.
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 3 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: status not confirmed, as of the sponsor's last update on 7 Feb 2017. 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 Denmark. 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?
Results are not available in the source record.
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?
Within group difference in Glucagon-like Peptide 1 secretion (evaluated by iAUC). (time frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240). 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 7 Feb 2017.