Prospective Study of Hormone Levels After Bariatric Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Judith Korner, Columbia University
ClinicalTrials.gov Identifier:
NCT00627315
First received: February 28, 2008
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to measure levels of hormones involved in appetite and body weight regulation before and after bariatric surgery.


Condition Intervention
Obesity
Behavioral: meal test and intravenous catheter placement
Other: Observational
Other: intravenous catheter placement and blood collection

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:
  • Measures of gut hormones, insulin and leptin [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measures of hunger and satiety [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood samples


Estimated Enrollment: 60
Study Start Date: April 2003
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Obese adult men and women who are undergoing bariatric surgery
Behavioral: meal test and intravenous catheter placement
meal test and intravenous catheter placement with serial blood draws
Other Name: Meal test for blood draws and appetite scores
Other: Observational
Observational
Other: intravenous catheter placement and blood collection
liquid meal test and blood collection from an intravenous catheter

Detailed Description:

Morbid obesity is a major public health problem. In this country, surgical treatment has offered the most successful option for long term therapy in this disease. However, several types of such surgery may have undesirable effects on calcium metabolism and the skeleton. In this study, the investigators will assess the effect different types of surgery for obesity such as, but not limited to, gastric bypass (GBP), Biliary Pancreatic Diversion (BPD), gastric banding (GB) or sleeve gastrectomy, on indices of calcium and skeletal metabolism. The investigators will also evaluate the effects of bariatric surgery on circulating levels of hormones that regulate energy balance.

The specific aims are:

  1. To determine whether and to what extent parathyroid hormone (PTH) increases following gastric bypass and gastric banding procedures for obesity.
  2. To determine whether and to what extent serum calcium and vitamin D levels fall following gastric bypass and gastric banding.
  3. To evaluate whether there is a change in bone turnover markers following gastric bypass and gastric banding.
  4. To determine changes in bone density at the distal radius following gastric bypass and gastric banding, over a 5 years period.
  5. To determine what percentage of obese subjects presenting for evaluation have vitamin D deficiency preoperatively.
  6. To determine the effects of bariatric surgery on circulating levels of gastrointestinal peptides that regulate appetite and food intake such as ghrelin, peptide YY(336), glucagonlike peptide 1 (GLP1), and gastric inhibitor polypeptide (GIP).
  7. To determine if there is a correlation between appetite hormones and the degree of weight loss, appetite, and maintenance of a reduced body weight over a 5 years period.
  8. To establish collaborations with other investigators who have the ability to measure metabolites and hormones involved in glucose and energy homeostasis with techniques and reagents that are not available in our laboratory.
  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

Adults undergoing bariatric surgery

Criteria

Inclusion Criteria:

  • Adults undergoing gastric bypass or gastric banding

Exclusion Criteria:

  • Poor intravenous access

NOTE: This study does not pay for the 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
Investigators
Principal Investigator: Judith Korner, MD,PhD Columbia University
  More Information

No publications provided

Responsible Party: Judith Korner, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT00627315     History of Changes
Other Study ID Numbers: AAAB0528, R01DK072011, DK072011
Study First Received: February 28, 2008
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014