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

NCT03046147 | Unknown

• 1 other identifier: KBM-IS-Bone
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Bypass Surgery; Obesity; Bone Loss

Outcome Measures

Primary Outcomes (2)

• Changes in bone mineral density of non-weight bearing bone

  DXA scans of forearm

  1 year, 4 years

• Changes in bone mineral density of weightbearing bone

  DXA scans of hip and lumbal columna

  1 year, 4 years

Secondary Outcomes (2)

• Plasma markers of bone turnover

  1 week, 3 months, 1 year, 4 years

• Plasma markers of bone turnover

  3 months, 1 year, 4 years

Study Arms (2)

RYGB patients with preoperative type diabetes

Recruited from a previously investigated cohort (NCT 01202526)

Procedure: Roux-en-Y gastric bypass

RYGB patients with preoperative normal glucose tolerance

Recruited from a previously investigated cohort (NCT 01202526)

Procedure: Roux-en-Y gastric bypass

Interventions

Roux-en-Y gastric bypass PROCEDURE

Roux-en-Y gastric bypass surgery for morbid obesity

RYGB patients with preoperative normal glucose tolerance; RYGB patients with preoperative type diabetes

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from a previously investigated cohort of 20 subjects undergoing Roux-en-Y gastric bypass surgery (NCT 01202526). The previous study aimed at investigating acute and long term changes in insulin sensitivity and secretion, whereas the present follow-up study investigates changes in bone metabolism as the primary outcome.

You may qualify if:

• Participation in previos study ((NCT 01202526)

You may not qualify if:

• Treatment of osteoporosis

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Copenhagen University hospital Hvidovre

Copenhagen, 2820, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum

MeSH Terms

Conditions

Obesity; Bone Diseases, Metabolic

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Central Study Contacts

Kirstine N Bojsen-Møller, MD, PhD

CONTACT

4538626371; kirstine.bojsen-moeller@regionh.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 8, 2017
• Study Start: September 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 8, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)