The Effect of Different Macronutrients on Gastrointestinal Hormone Secretion After Gastric Bypass Operation

February 6, 2017 updated by: Kirstine Nyvold Bojsen-Moeller
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Hvidovre, Copenhagen, Denmark, 2650
        • Endocrinology Research Center, Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

RYGB Patients:

Inclusion Criteria:

  • Underwent RYGB surgery more than 18 months earlier, weight stabile (+/- 5 kg during 1 month)

Exclusion Criteria:

  • 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:

Inclusion Criteria:

  • Have not underwent bariatric surgery.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutes
Other Names:
  • LACPRODAN SP-9225 INSTANT Whey Protein Isolate
Other: Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutes
Other Names:
  • Lurpak® smør(butter) 81% fat
Other: Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes
Other Names:
  • Urtegaarden Druesukker (Dextrose monohydrat)
Other: Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes
Other Names:
  • Lurpak® smør(butter) 81% fat with 120 mg Xenical® Orlistat
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.
Other: Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutes
Other Names:
  • LACPRODAN SP-9225 INSTANT Whey Protein Isolate
Other: Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutes
Other Names:
  • Lurpak® smør(butter) 81% fat
Other: Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes
Other Names:
  • Urtegaarden Druesukker (Dextrose monohydrat)
Other: Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes
Other Names:
  • Lurpak® smør(butter) 81% fat with 120 mg Xenical® Orlistat

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Within group difference in Glucagon secretion (evaluated by iAUC).
Time Frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
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
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
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
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
0, 30, 45, 60, 120, 180, 240
Within group difference in Changes in bile acids.
Time Frame: 0, 30, 45, 60, 120, 180, 240
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
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
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
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
Hunger, satiety, abdominal pain and nausea measured by standard 10 cm Visual Analog Scale
0, 30, 60, 90, 120, 180, 240
Within group difference in Ad libitum food intake (grams).
Time Frame: 240
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
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
0, 15, 30, 45, 60, 90, 120, 180, 240

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Between groups 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 Gastric bypass operated patients and Healthy volunteers.
Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Between groups difference in Glucagon secretion (evaluated by iAUC).
Time Frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Between groups difference in Glucose-dependent insulinotropic peptide secretion (evaluated by iAUC).
Time Frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Between groups difference in Cholecystokinin secretion (evaluated by iAUC).
Time Frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Between groups difference in Peptide YY 3-36 secretion (evaluated by iAUC).
Time Frame: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
Between groups difference in Ghrelin secretion (evaluated by iAUC).
Time Frame: 0, 30, 45, 60, 120, 180, 240
0, 30, 45, 60, 120, 180, 240
Between groups difference in Changes in bile acids.
Time Frame: 0, 30, 45, 60, 120, 180, 240
0, 30, 45, 60, 120, 180, 240
Between groups difference in Changes in glycerol, triacylglycerol and free fatty acids.
Time Frame: 0, 30, 45, 60, 120, 180, 240
0, 30, 45, 60, 120, 180, 240
Between groups difference in Insulin secretion (evaluated by iAUC).
Time Frame: 2xBasline, 0, 10, 15, 20, 30, 40, 45, 60, 90, 120, 180, 240
2xBasline, 0, 10, 15, 20, 30, 40, 45, 60, 90, 120, 180, 240
Between groups difference in Plasma glucose concentration.
Time Frame: 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240
2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240
Between groups difference in Visual Analog Scale.
Time Frame: 0, 30, 60, 90, 120, 180, 240
Hunger, satiety, abdominal pain and nausea measured by standard 10 cm Visual Analog Scale
0, 30, 60, 90, 120, 180, 240
Between groups difference in Ad libitum food intake (grams).
Time Frame: 240
240
Between groups difference in Heart rate (bpm).
Time Frame: 2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240
2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240
Between groups difference in Blood pressure (mmhg).
Time Frame: 0, 15, 30, 45, 60, 90, 120, 180, 240
0, 15, 30, 45, 60, 90, 120, 180, 240

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kirstine Nyvold Bojsen-Moeller

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CZJ-MA-14

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