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Long-term Adverse Effects After Bariatric Surgery on Bone Density (FUB-A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03410459
Recruitment Status : Completed
First Posted : January 25, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on bone mineral density, fracture risk, and body composition ≥ 5 years post-surgery.

Condition or disease Intervention/treatment Phase
Morbid Obesity Diagnostic Test: DEXA (= Dual-energy x-ray absorptiometry) Not Applicable

Detailed Description:

Bariatric surgery shows impressive results in terms of weight loss and resolution of comorbidities. Still, there are questions as to the frequency of long-term adverse effects: data on alterations in bone health are missing,

The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on bone mineral density, fracture risk, and body composition ≥ 5 years post-surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Long-term Adverse Effects After Laparoscopic Sleeve Gastrectomy and Roux en Y Gastric Bypass (Part A)
Actual Study Start Date : February 2, 2018
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Density X-Rays
Drug Information available for: X-Rays

Arm Intervention/treatment
Active Comparator: Gastric Bypass
Patients ≥ 5 years after laparoscopic gastric bypass receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density
Diagnostic Test: DEXA (= Dual-energy x-ray absorptiometry)
measurement of vertebral bone and hip bone mineral density

Active Comparator: Sleeve gastrectomy
Patients ≥ 5 years after laparoscopic sleeve gastrectomy receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density
Diagnostic Test: DEXA (= Dual-energy x-ray absorptiometry)
measurement of vertebral bone and hip bone mineral density




Primary Outcome Measures :
  1. Total hip T-Score measured with dual-energy x-ray absorptiometry [ Time Frame: 5-7 years after bariatric surgery ]
    measured score will be compared to reference score for this age


Secondary Outcome Measures :
  1. Total vertebral T-Score measured with dual-energy x-ray absorptiometry [ Time Frame: 5-7 years after bariatric surgery ]
    measured score will be compared to reference score for this age

  2. fracture risk assessed by FRAX score [ Time Frame: 5-7 years after bariatric surgery ]
    measured score will be compared to reference score for this age

  3. plasma concentration of C-terminal telopeptide (CTX) [ Time Frame: 5-7 years after bariatric surgery ]
    measured plasma concentration will be compared to reference for this age

  4. plasma concentration of vitamin D3 [ Time Frame: 5-7 years after bariatric surgery ]
    measured plasma concentration will be compared to reference for this age



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who received laparoscopic sleeve gastrectomy (LSG) or laparoscopic gastric bypass (LRYGB) ≥ 5 years ago as a primary bariatric procedure will be eligible for this study.

Exclusion Criteria:

  • LSG or LRYGB as a secondary bariatric procedure (e.g. after gastric banding), patients receiving secondary bariatric operation after LSG resp LRYGB (e.g. biliopancreatic diversion), pregnancy (due to radiation exposition)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410459


Locations
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Switzerland
St Claraspital
Basel, Switzerland, 4016
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Bettina K Wölnerhanssen, MD Clinical Research St. Claraspital Basel
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03410459    
Other Study ID Numbers: FUB Study Bone
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity, Morbid
Long Term Adverse Effects
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Pathologic Processes