Prospective Study of Hormone Levels After Bariatric Surgery

Prospective Study of Hormone Levels and Appetite After Bariatric Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00627315

Enrollment

236

Registered

2008-03-03

Start date

2003-03-17

Completion date

2018-11-04

Last updated

2019-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

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

Brief summary

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

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, parathyroid hormone (PTH) and vitamin D, and assessment of skeletal health using markers of bone turnover and bone mineral density.

Interventions

PROCEDUREGastric bypass

NOTE: Surgery will not be paid by the study

PROCEDUREGastric banding

NOTE: Surgery will not be paid by the study

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change in body weight	5 years	linear mixed model analysis will be used to study change over time and between surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026