Insulin ResistanceNCT03371368
Metabolism and Bariatric Surgery Study
A study testing Roux-en-Y Gastric Bypass (RYGBP), Sleeve Gastrectomy (SG) and Very Low Calorie Diet (VLCD) in people with Insulin Resistance and Obesity, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Obesity
- What is being tested?
- Roux-en-Y Gastric Bypass (RYGBP), Sleeve Gastrectomy (SG) and Very Low Calorie Diet (VLCD)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 24 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women Ages 18-65 Years Old
Who cannot join
- Altered Sleep-wake Cycle
- Type 1 or 2 Diabetes
- Previous Bariatric Surgery
- Lactose Intolerance
- Any Special Diet restrictions.
- Use of medications that may affect body weight at screening or during a 3-month period prior.
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- Untreated thyroid disease
- Other medical conditions like Cushing's, acromegaly, Hearth failure, Crohn's disease, etc.
- Pregnancy
- Tobacco or opioid use
- Alcohol dependence
- > 3% weight change over the 3month period prior to screening
- Unwillingness to maintain current level of physical activity over duration of study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: 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 weight loss (WL) interventions and a lean and an obese healthy control group.
Read the 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.
- Conditions
- Insulin Resistance, Obesity
- Being tested
- Roux-en-Y Gastric Bypass (RYGBP), Sleeve Gastrectomy (SG), Very Low Calorie Diet (VLCD)
- Keywords
- Obesity, Insulin Resistance, Bariatric Surgery, Gastric Bypass, Sleeve Gastrectomy
- Medical subject headings
- Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y Gastric Bypass (RYGBP)Procedure or surgery
Also called RYGBP
This is a standard RYGBP procedure that would be performed clinically and is not research-specific.
Sleeve Gastrectomy (SG)Procedure or surgery
Also called SG
This is a standard SG procedure that would be performed clinically and is not research-specific.
Very Low Calorie Diet (VLCD)Behavioural
Also called VLCD
Weight loss with calorie restricted liquid diet. Subjects will be placed on a 800 kcal/day diet with a meal replacement (Optifast) provided by the investigator for 12 weeks. Then, transitioning to a higher calorie diet intake up to a year. Subjects will be closely monitored by study dietitian
| Study group | Role | What they receive |
|---|---|---|
| Gastric Bypass Diabetic and Non-diabetic | Other | Roux-en-Y gastric bypass surgery Receives: Procedure: Roux-en-Y Gastric Bypass (RYGBP) |
| Sleeve Gastrectomy Diabetic and Non-diabetic | Other | sleeve gastrectomy surgery Receives: Procedure: Sleeve Gastrectomy (SG) |
| Very Low Calorie Diet Diabetic and Non-diabetic | Active comparator | very low calorie diet Receives: Behavioral: Very Low Calorie Diet (VLCD) |
| Obese Control Group | No intervention | Non-diabetic obese subjects |
| Lean Control Group | No intervention | Non-diabetic lean subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urine free cortisol level
A linear mixed effects model will be used to compare the cortisol changes between the LCD and the surgery groups. Specifically, cortisol change will be modeled as longitudinal outcome, and the main predictors are time and treatment group, and the time-treatment interaction.
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start16 Oct 2017
- Primary completion24 Apr 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cohort
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith Korner, Columbia University
- Investigators
- Judith Korner, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371368
- Sponsor's protocol ID
- AAAR3662
- Other IDs
- R01DK072011
- Status last verified
- May 2025
- First submitted
- 7 Dec 2017
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Endocrine Effects of Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03371368
- Acronym / sponsor ID
- AAAR3662
- Conditions
- Insulin Resistance, Obesity
- Keywords
- Obesity, Insulin Resistance, Bariatric Surgery, Gastric Bypass, Sleeve Gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Cohort
| Arm | Type | Receives |
|---|---|---|
| Gastric Bypass Diabetic and Non-diabetic | Other | Procedure: Roux-en-Y Gastric Bypass (RYGBP)Roux-en-Y gastric bypass surgery |
| Sleeve Gastrectomy Diabetic and Non-diabetic | Other | Procedure: Sleeve Gastrectomy (SG)sleeve gastrectomy surgery |
| Very Low Calorie Diet Diabetic and Non-diabetic | Active comparator | Behavioral: Very Low Calorie Diet (VLCD)very low calorie diet |
| Obese Control Group | No intervention | –Non-diabetic obese subjects |
| Lean Control Group | No intervention | –Non-diabetic lean subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women Ages 18-65 Years Old
Key exclusion criteria (13 listed)
- Altered Sleep-wake Cycle
- Type 1 or 2 Diabetes
- Previous Bariatric Surgery
- Lactose Intolerance
- Any Special Diet restrictions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y Gastric Bypass (RYGBP)Also: RYGBPThis is a standard RYGBP procedure that would be performed clinically and is not research-specific. | Procedure or surgery | Gastric Bypass Diabetic and Non-diabetic |
| Sleeve Gastrectomy (SG)Also: SGThis is a standard SG procedure that would be performed clinically and is not research-specific. | Procedure or surgery | Sleeve Gastrectomy Diabetic and Non-diabetic |
| Very Low Calorie Diet (VLCD)Also: VLCDWeight loss with calorie restricted liquid diet. Subjects will be placed on a 800 kcal/day diet with a meal replacement (Optifast) provided by the investigator for 12 weeks. Then, transitioning to a higher calorie diet intake up to a year. Subjects will be closely monitored by study dietitian | Behavioural | Very Low Calorie Diet Diabetic and Non-diabetic |
Primary outcome
Change in urine free cortisol level
Time frame: Baseline and 1 year
A linear mixed effects model will be used to compare the cortisol changes between the LCD and the surgery groups. Specifically, cortisol change will be modeled as longitudinal outcome, and the main predictors are time and treatment group, and the time-treatment interaction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Korner, MD, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y Gastric Bypass (RYGBP), Sleeve Gastrectomy (SG) and Very Low Calorie Diet (VLCD) in people with Insulin Resistance and Obesity, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urine free cortisol level (time frame: Baseline and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025; AzTrials last refreshed its copy on 1 Nov 2026.