The Effect of Gastric Bypass Surgery on Gut Hormones Related to Bone Remodeling and Intestinal Growth.

The overall purpose is to explore the link between the gut and the bones by investigating meal stimulated changes in the blood level of a number of hormones and markers related to intestinal growth and bone turnover in patients undergoing surgery for obesity (gastric bypass). The hormones will be measured in blood samples taken before and after surgery. The results are compared with changes in body weight and body composition as measured by DEXA scanning.

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Key information

Conditions

Obesity Body Weight Bone Diseases Bone Diseases, Metabolic Bone Loss Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of Roskilde-Koege, The University of Copenhagen

Koege, DK-4600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Caucasians fulfilling the criteria for laparoscopic gastric bypass.
BMI>40kg/m2.

Exclusion criteria

Pregnancy
Chronic obstructive pulmonary disease
Diabetes mellitus
Chronic inflammatory bowel disease
Major psychiatric disorder
Drug abuse

Treatment and study plan

Meal test and dexa scan

Other

Body composition is determined by whole body deca scan and bone mineral density is determined dy dexa scans of the lumbar spine and the proximal femur.

Primary outcomes

Meal stimulated changes in gut hormones and bone markers.

Time frame: Before surgery and 4 weeks and 6 months after surgery.

Secondary outcomes

Changes in bone mass and body composition.

Time frame: Before surgery and 6 months after surgery.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

Zealand University Hospital

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Oct 4, 2012
Registry last updated: Dec 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed