The Effect of Roux-en-Y Gastric Bypass on Bone Turnover

NCT ID: NCT03046147

Last Updated: 2017-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-09-30

Brief Summary

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Bone mineral density (BMD) is decreased after Roux-en-Y gastric bypass (RYGB) but whether RYGB induces changes in BMD beyond adaptation to major weight loss is not known. We aim to investigate BMD changes in weight bearing (hip, lumbal columna) and in non-weight bearing (forearm) regions before and after maximal weight loss at 1 year and after weight stabilisation at 4 years after RYGB. Moreover, plasma markers of bone turnover will be studied at fasting and during oral glucose tolerance test.

Detailed Description

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Conditions

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Gastric Bypass Surgery Obesity Bone Loss

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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RYGB patients with preoperative type diabetes

Recruited from a previously investigated cohort (NCT 01202526)

Roux-en-Y gastric bypass

Intervention Type PROCEDURE

Roux-en-Y gastric bypass surgery for morbid obesity

RYGB patients with preoperative normal glucose tolerance

Recruited from a previously investigated cohort (NCT 01202526)

Roux-en-Y gastric bypass

Intervention Type PROCEDURE

Roux-en-Y gastric bypass surgery for morbid obesity

Interventions

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Roux-en-Y gastric bypass

Roux-en-Y gastric bypass surgery for morbid obesity

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Participation in previos study ((NCT 01202526)

Exclusion Criteria

* Treatment of osteoporosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kirstine Nyvold Bojsen-Moeller

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Copenhagen University hospital Hvidovre

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Kirstine N Bojsen-Møller, MD, PhD

Role: CONTACT

4538626371

Facility Contacts

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Kirstine N Bojsen-Møller, MD, PhD

Role: primary

4538626371

Other Identifiers

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KBM-IS-Bone

Identifier Type: -

Identifier Source: org_study_id

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