Metabolism and Bariatric Surgery Study
Status: | Recruiting |
---|---|
Conditions: | Obesity Weight Loss, Endocrine |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 12/15/2017 |
Start Date: | October 16, 2017 |
End Date: | June 30, 2023 |
Contact: | Judith Korner, MD, PhD |
Email: | jk181@cumc.columbia.edu |
Phone: | (212) 305-3725 |
Metabolic and Endocrine Effects of Bariatric Surgery
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 WL
interventions and a lean and an obese healthy control group.
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 WL
interventions and a lean and an obese healthy control group.
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 recidivism and
the paucity of safe, effective and affordable pharmacotherapy 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.
(DM). Unfortunately, WL through life-style interventions has a high degree of recidivism and
the paucity of safe, effective and affordable pharmacotherapy 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.
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
We found this trial at
1
site
630 W 168th St
New York, New York
New York, New York
212-305-2862
Phone: 212-305-3725
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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