Completed

Gut Hormones and Bone Remodeling Changes After Gastric Bypass Surgery

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Study Aim

This study aims to observe how gut hormones and bone remodeling markers change in response to meals after gastric bypass surgery.

What is being collected

Data Collection

Collected from today forward - Prospective
OtherNo DNA Sample
Who is being recruted

Body Weight+9

+ Bone Diseases

+ Metabolic Diseases

From 18 to 65 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: October 2011
See protocol details

Summary

Principal SponsorUniversity of Copenhagen
Last updated: December 17, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2011

Actual date on which the first participant was enrolled.

This study focuses on understanding the connection between the gut and bones. It looks at how meal-stimulated changes in blood levels of various hormones and markers related to intestinal growth and bone turnover are affected in patients undergoing gastric bypass surgery for obesity. The goal is to gain insights into how weight loss surgery might influence these hormones and markers, potentially impacting bone health and intestinal growth. Participants in this observational study will have their hormone levels measured through blood samples taken before and after gastric bypass surgery. The primary outcome of interest is the change in these gut hormones and bone markers in response to meals. These results will then be compared with changes in body weight and body composition, which will be measured using DEXA scanning.

Principal SponsorUniversity of Copenhagen
Last updated: December 17, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

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

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightBone DiseasesMetabolic DiseasesMusculoskeletal DiseasesNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweightBone Diseases, MetabolicObesity

Criteria

2 inclusion criteria required to participate
BMI > 40kg/m2

Caucasians fulfilling the criteria for laparoscopic gastric bypass

6 exclusion criteria prevent from participating
Chronic inflammatory bowel disease

Chronic obstructive pulmonary disease

Diabetes mellitus

Drug abuse

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hospital of Roskilde-Koege, The University of Copenhagen

Koege, DenmarkOpen Hospital of Roskilde-Koege, The University of Copenhagen in Google Maps
CompletedOne Study Center