Trial record 2 of 2 for:    "Vitamin E Deficiency" OR "ataxia with vitamin E deficiency"

Complications After Bariatric Surgery - a Clinical Trial

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01930838
First received: August 22, 2013
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

The number of obese is increasing rapidly. Bariatric surgery is used to a greater and greater extent as treatment of obesity to obtain a greater and more permanent weight loss. The currently most commonly used surgical method is the gastric bypass (RYGB), which so far has proved to be the most effective way to achieve a greater and more permanent weight loss, reduction and maybe even elimination of many of the obesity-related health complication (diabetes, sleep apnea, pain due to osteoarthrosis etc.).

Bariatric surgery, including RYGB is also associated with medical and nutritional complications. This will be a natural consequence of the fact that the food bypasses virtually the entire ventricle and 100-150 cm of the upper part of the small intestine after a RYGB. Therefore, problems with uptake of for example B12, iron, folate, thiamin, fat-soluble vitamins (Vitamins A, D, E and K) copper, zinc and selenium are expected. In the light of this, it is decided that all RYGB operated patients must take vitamin B12, iron and vitamin D substitution. In spite of this, many develop various nutritional problems after RYGB. In addition to these nutritional complications are complications such as hypoglycaemia and gallstone attacks after RYGB.

Nevertheless there is no comprehensive inventory of the occurrence of nutritional complications after bariatric surgery neither in Denmark nor in an international context. Thus there is no consensus on an optimal postoperative prevention of complications. An overview of the occurrence of these problems will be important for assessing and determine the indications for bariatric surgery as well as to optimize the prevention of complications.

To enlighten this the investigators will conduct a clinical trial concerning complications after RYGB. The investigators will examine 350 RYGB operated patients the Central Denmark Region. From a medical interview, blood tests, Dual energy X-ray absorptiometry etc. it will be possible to give a good estimate of the incidence of medical complications. The investigators will explore complications such as: anemia, hypoglycemia, peripheral nerve problems (especially neuropathies), vitamin D / osteoporosis and other mineral / vitamin deficiencies that may be identified through blood tests. A control group of 30-40 age, sex and body mass index matched individuals will go through the same examinations.


Condition Intervention
Complications After Gastric Bypass Operation
Procedure: Gastric bypass operation

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Month
Official Title: Prevalence of Medical and Nutritional Complications After Bariatric Surgery (Gastric Bypass) Based on a Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Number of participants with complications [ Time Frame: 2-7 years ] [ Designated as safety issue: No ]
    By clinical examinations, blood tests, Dual energy X-ray absorptiometry and urine will be performed


Biospecimen Retention:   Samples With DNA

Whole blood Urine


Estimated Enrollment: 400
Study Start Date: February 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Controls
Matched on age, sex and body mass index
Gastric bypass operation
Patients with gastric bypass operation between 2006 and 2011 in The Central Denmark Region
Procedure: Gastric bypass operation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All gastric bypass operated residents in The Central Denmark Region between 2006 and 2011.

Criteria

Inclusion Criteria:

  • gastric bypass operation 2006-2011
  • resident in The Central Denmark Region

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930838

Contacts
Contact: Sigrid Bjerge Gribsholt, MD +4561651148 sigrgrib@rm.dk
Contact: Joan Bach Nielsen, MD joannils@rm.dk

Locations
Denmark
Department of Endocrinology and Metabolism, Aarhus University Hospital Not yet recruiting
Aarhus, Denmark, 8000
Contact: Sigrid Bjerge Gribsholt, MD    +4561651148    sigrgrib@rm.dk   
Contact: Joan Bach Nielsen, MD       joannils@rm.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
Study Chair: Bjørn Richelsen, Professor, DMSc Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01930838     History of Changes
Other Study ID Numbers: 1-10-72-191-13
Study First Received: August 22, 2013
Last Updated: September 3, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Bariatric surgery
Complications
Osteoporosis
Neuropathy
Vitamine deficiency

ClinicalTrials.gov processed this record on July 24, 2014