Prospective Study of Hormone Levels After Bariatric Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Columbia University
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Judith Korner, Columbia University
ClinicalTrials.gov Identifier:
NCT00627315
First received: February 28, 2008
Last updated: October 13, 2015
Last verified: October 2015
  Purpose
This project will study the effects of surgery for obesity on bone metabolism and hormones that regulate appetite.

Condition Intervention
Obesity
Procedure: Gastric bypass
Procedure: Gastric banding

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study of Hormone Levels and Appetite After Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Change in bone density [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in serum calcium and vitamin D levels [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Change in parathyroid hormone (PTH) level [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
blood samples

Estimated Enrollment: 240
Study Start Date: March 2015
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Surgery
Obese adult men and women who are undergoing bariatric surgery (gastric bypass or gastric banding).
Procedure: Gastric bypass
NOTE: Surgery will not be paid by the study
Other Name: GBP
Procedure: Gastric banding
NOTE: Surgery will not be paid by the study
Other Name: GB

Detailed Description:

Subjects will be recruited from the outpatient obesity and surgical clinics at Columbia-Presbyterian Medical Center after they have chosen to undergo a surgical procedure. The groups will not be randomized. Rather, they will decide on their choice of surgery along with their physicians. The patients will be evaluated pre-operatively and followed post-operatively for 5 years.

Initial evaluation will include a complete history and physical examination, measurement of calcium, PTH and vitamin D, and assessment of skeletal health using markers of bone turnover and bone mineral density.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from the outpatient obesity and surgical clinics at Columbia-Presbyterian Medical Center after they have chosen to undergo a surgical procedure.
Criteria

Inclusion criteria:

  1. Adult male or female > 18 years of age
  2. Scheduled to undergo bariatric surgery

Exclusion criteria:

  1. Vitamin D deficiency
  2. Primary hyperparathyroidism
  3. Treatment with lithium or thiazide diuretics which may alter PTH levels
  4. Osteomalacia
  5. Untreated hyperthyroidism, liver disease, Cushing's syndrome, rheumatoid arthritis, myeloma or Paget's disease
  6. Impaired renal function (serum creatinine >2.0mg/dl) or history of renal osteodystrophy
  7. Use of any anti-obesity medications for over 2 weeks 90 days prior to study
  8. Participation in any research study 90 days prior to study
  9. Any malabsorption syndromes such as celiac sprue
  10. Previous bariatric surgery
  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: NCT00627315

Contacts
Contact: Gerardo Febres, MD 212-342-0281 gjf41@columbia.edu
Contact: Judith Korner, MD, PhD 212 305-3725 jk181@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Gerardo Febres, MD    212-342-0281      
Contact: Judith Korner, MD, PhD    212 305-3725    jk181@columbia.edu   
Sponsors and Collaborators
Columbia University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Judith Korner, MD,PhD Columbia University
  More Information

Responsible Party: Judith Korner, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT00627315     History of Changes
Other Study ID Numbers: AAAB0528  R01DK072011 
Study First Received: February 28, 2008
Last Updated: October 13, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Obesity
Insulin Resistance
Bariatric Surgery
Gastric Banding
Gastric Bypass

ClinicalTrials.gov processed this record on May 23, 2016