Clinical trial NCT03371368: Metabolism and Bariatric Surgery Study
Official title: Metabolic and Endocrine Effects of Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Obesity
Keywords: Obesity
Insulin Resistance
Bariatric Surgery
Gastric Bypass
Sleeve Gastrectomy
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-12-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cohort
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if diet-induced weight loss causes different changes in hormones that control appetite and glucose control than surgery-induced weight loss. The overall research plan is a non-randomized prospective study of 3 different weight loss (WL) interventions and a lean and an obese healthy control group.

Detailed description: Weight loss (WL) improves obesity-related co-morbidities such as type 2 diabetes mellitus (DM). Unfortunately, WL through life-style interventions has a high degree of relapse and the lack of safe, effective and affordable therapies together with an increase in the prevalence of morbid obesity has led to a rise in bariatric procedures. Clinical trials in patients with DM show that improvements in glycemia vary between procedures and occur in the following order: Roux-en-Y gastric bypass (RYGB) \> sleeve gastrectomy (SG) \> laparoscopic adjustable gastric banding (LAGB) \> medical/life-style therapy. This order mirrors the amount of WL with each intervention and is a major driver of glycemic improvement. The investigators have shown profound changes unique to RYGB and SG in levels of hormones that make up the "gut-brain" and "enteroinsular" axes. The association of some of these hormones with insulin sensitivity (IS) and glycemia, independent of WL strongly suggests that glycemic improvements after surgery occur in part through pathways that are distinct from just calorie restriction. This study builds on results showing that levels of fibroblast growth factor 19 (FGF19), a protein secreted by intestinal cells, are increased after RYGB and SG but not after low calorie diet (LCD). This difference may affect hormones that control the stress response to weight loss. The investigators will explore differences in hormones of the gut that affect appetite, body weight, and stress response in healthy lean and obese individuals. Obese individuals will also be studied before and after 15% body weight loss induced by LCD, RYGB or SG, and again at 1 year after study enrollment.

Eligibility criteria: Inclusion Criteria:

Men and women Ages 18-65 Years Old

Exclusion Criteria:

1. Altered Sleep-wake Cycle
2. Type 1 or 2 Diabetes
3. Previous Bariatric Surgery
4. Lactose Intolerance
5. Any Special Diet restrictions.
6. Use of medications that may affect body weight at screening or during a 3-month period prior.
7. Untreated thyroid disease
8. Other medical conditions like Cushing's, acromegaly, Hearth failure, Crohn's disease, etc.
9. Pregnancy
10. Tobacco or opioid use
11. Alcohol dependence
12. \> 3% weight change over the 3month period prior to screening
13. Unwillingness to maintain current level of physical activity over duration of study period

Primary outcomes:
measure: Change in urine free cortisol level
timeFrame: Baseline and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Judith Korner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: