Prospective Study of Hormone Levels After Bariatric Surgery

NCT00627315 | Completed DMC

• 2 other identifiers: AAAB0528R01DK072011
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

This project will study the effects of surgery for obesity on bone metabolism and hormones that regulate appetite.

Conditions

Obesity

Keywords

Obesity; Insulin Resistance; Bariatric Surgery; Gastric Banding; Gastric Bypass

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  linear mixed model analysis will be used to study change over time and between surgery

  5 years

Study Arms (1)

Surgery

Obese adult men and women who are undergoing bariatric surgery (gastric bypass or gastric banding).

Procedure: Gastric bypass; Procedure: Gastric banding

Interventions

Gastric bypass PROCEDURE

NOTE: Surgery will not be paid by the study

Also known as: GBP

Surgery

Gastric banding PROCEDURE

NOTE: Surgery will not be paid by the study

Also known as: GB

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult male or female \> 18 years of age
• Scheduled to undergo bariatric surgery

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Judith Korner, MD,PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 3, 2008
• Study Start: March 17, 2003
• Primary Completion: November 4, 2018
• Study Completion: November 4, 2018
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

US (1)