ObesityNCT00627484
Changes in Insulin Sensitivity After Weight Loss
An observational study of Obesity and Type 2 Diabetes Mellitus, run by Columbia University at 1 site in United States.
Trial summary
This study is designed to compare the changes in insulin sensitivity as well as gastrointestinal hormone levels in diabetic and non-diabetic obese individuals who are undergoing weight loss procedures. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes Mellitus, Insulin Resistance
- What is being tested?
- Gastric bypass, Gastric banding and Sleeve gastrectomy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2005to 17 Jun 2018
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be recruited by physician referral and from outpatient obesity, bariatric surgical clinics and endocrinology clinics at Columbia University Medical Center as well as from the Medical Center Community and metropolitan area via IRB-approved flyers and internet postings. Subjects will also be recruited from the following website: www.craigslist.com using the same posting format of the IRB-approved flyers.
Who may be able to join
- Non-diabetic obese (BMI > 30) adult men and women between the ages of 18 and 75 scheduled to undergo
- gastric bypass (GBP)
- gastric banding (BND)
- Type 2 diabetes (HbA1c 6-12%) adult men and women between the ages of 18 and 75 scheduled to undergo gastric bypass.
- Type 2 diabetes (HbA1c 6-12%) adult men and women between the ages of 18 and 65 for weight reduction with a very low caloric diet (VLCD).
- Type 2 diabetes mellitus scheduled to undergo sleeve gastrectomy (SG).
Who cannot join
- Pregnancy.
- Age > 75 for surgery groups; Age > 65 for VLCD group.
- Treatment with glucocorticoids, anti-depressants, anti-psychotics, neuroleptics, weight loss medications, experimental medication.
- Greater than a 5% change in total body weight in the 90 days prior to the study.
- History of untreated gallstones; hepatic or renal insufficiency, abnormal thyroid stimulating hormone (TSH).
- Use of thiazolidinedione therapy.
Show all 12Show fewer
- HbA1c > 12%.
- Use of dipeptidyl peptidase IV (DPP-IV) inhibitor or glucagon-like peptide 1 receptor (GLP-1R) agonist for greater than 12 months within 3 months of the study.
- Fasting triglycerides > 400.
- Significant cardiovascular, neurologic, renal, gastrointestinal, or hematologic disease.
- Inability to comply with or understand the study protocol as ascertained by the PI.
- We will not exclude individuals with body weight > 145 kg, but we do recognize that such individuals are above the table weight limitations of the dual-energy x-ray absorptiometry (DEXA) scan and body composition data will be unavailable for those individuals.
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: Changes in Insulin Sensitivity After Weight Loss Induced by Diet or Bariatric Surgery
This study is designed to compare the changes in insulin sensitivity as well as gastrointestinal hormone levels in diabetic and non-diabetic obese individuals who are undergoing weight loss procedures. The main hypothesis of this study is that weight loss induced by gastric bypass will induce a greater improvement in insulin sensitivity compared with gastric banding or low calorie diet. Subjects will be studied before and after weight loss. Studies consist of intravenous glucose tolerance test, body composition analysis, meal test, and energy expenditure.
Read the detailed description
Patients who are scheduled for gastric bypass (GBP), sleeve gastrectomy (SG), or simple caloric restriction with gastric banding (BND) or a very low calorie diet (VLCD) will be examined at baseline weight, and when 6-10% total body weight has been lost. We will measure insulin sensitivity with an intravenous glucose tolerance test, and fasting levels of hormones that regulate food intake and insulin sensitivity, such as ghrelin, peptide YY (PYY), glucagon-like peptide 1 (GLP1) and leptin. Fat mass and skeletal muscle mass will be measured by dual photon absorptiometry (DXA). We will also measure the hormonal and thermic response to food with a liquid test meal and energy expenditure by indirect calorimetry. This measures how many calories are burned at rest and the in response to food. Subjects with diabetes will continue to be studied with the same protocol on an annual basis out to 5 years in order to determine the rate of remission of diabetes and the durability of this effect as subjects tend to regain some body weight over time.
Subjects with diabetes will also be followed every three months for the first year after the initial weight loss for HbA1c and fasting glucose levels. The results of this study may lead to new understanding about changes in insulin sensitivity, body composition and hormonal profile, as well as changes in energy expenditure with weight loss after bariatric surgery or with simple caloric restriction. With this greater understanding, new treatments for obesity and diabetes, that do not require surgery, may be developed.
- Conditions
- Obesity, Type 2 Diabetes Mellitus, Insulin Resistance
- Being tested
- Gastric bypass, Gastric banding, Sleeve gastrectomy, Very low calorie diet
- Keywords
- Insulin resistance, Insulin sensitivity, bariatric surgery, diabetes, calorie restriction, body composition
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Insulin Resistance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric bypassProcedure or surgery
Also called GBP
NOTE: the surgery is not paid for by the study
Gastric bandingProcedure or surgery
Also called BND
NOTE: the surgery is not paid for by the study
Sleeve gastrectomyProcedure or surgery
Also called SG
NOTE: the surgery is not paid for by the study
Very low calorie dietBehavioural
Also called VLCD
Weight loss with calorie restricted liquid diet. Subject will be asked to stay in our in-patient research unit for 2-3 weeks and consume only those foods supplied by our bionutrition unit. Expected weight loss should be between 7-10% of body weight. Subjects will receive the diet at no cost and will be compensated for their time.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: GBP non-diabetic | Non-diabetic subjects scheduled to receive gastric bypass Receives: Procedure: Gastric bypass | |
| Group 2: BND non-diabetic | Non-diabetic subjects scheduled to receive gastric banding Receives: Procedure: Gastric banding | |
| Group 3: GBP diabetic | Diabetic subjects scheduled to receive gastric bypass Receives: Procedure: Gastric bypass | |
| Group 4: VLCD diabetic | Diabetic subjects scheduled to receive very low calorie diet Receives: Behavioral: Very low calorie diet | |
| Group 5: SG diabetic | Diabetic subjects scheduled to receive sleeve gastrectomy Receives: Procedure: Sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insulin Sensitivity
Measured by frequently sampled intravenous glucose tolerance test (FSIVGTT)
Measured: 2-8 weeks
Secondary outcomes (2)
Change in Body Composition
Measured by dual energy x-ray absorptiometry (DXA)
Measured: 2-8 weeks
Change in Resting Energy Expenditure
Measured by indirect calorimetry using a Hood Calorimeter
Measured: Up to 4 hrs post-meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study start1 Mar 2005
- Primary completion17 Jun 2018
- Study completion17 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 119 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
- NCT00627484
- Sponsor's protocol ID
- AAAB2401
- Other IDs
- R21DK081050, DK072011
- Status last verified
- Sep 2019
- First submitted
- 28 Feb 2008
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Jackness C, Karmally W, Febres G, Conwell IM, Ahmed L, Bessler M, McMahon DJ, Korner J. Very low-calorie diet mimics the early beneficial effect of Roux-en-Y gastric bypass on insulin sensitivity and beta-cell Function in type 2 diabetic patients. Diabetes. 2013 Sep;62(9):3027-32. doi: 10.2337/db12-1762. Epub 2013 Apr 22.
PubMed 23610060
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Insulin Sensitivity After Weight Loss Induced by Diet or Bariatric Surgery
- ClinicalTrials.gov ID
- NCT00627484
- Acronym / sponsor ID
- AAAB2401
- Conditions
- Obesity, Type 2 Diabetes Mellitus, Insulin Resistance
- Keywords
- Insulin resistance, Insulin sensitivity, bariatric surgery, diabetes, calorie restriction, body composition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Mar 2005 (actual)
- Primary completion
- 17 Jun 2018 (actual)
- Study completion
- 17 Jun 2018 (actual)
- First posted
- 3 Mar 2008 (estimated)
- 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.
This study is designed to compare the changes in insulin sensitivity as well as gastrointestinal hormone levels in diabetic and non-diabetic obese individuals who are undergoing weight loss procedures. The main hypothesis of this study is that weight loss induced by gastric bypass will induce a greater improvement in insulin sensitivity compared with gastric banding or low calorie diet. Subjects will be studied before and after weight loss. Studies consist of intravenous glucose tolerance test, body composition analysis, meal test, and energy expenditure.
Detailed description
Patients who are scheduled for gastric bypass (GBP), sleeve gastrectomy (SG), or simple caloric restriction with gastric banding (BND) or a very low calorie diet (VLCD) will be examined at baseline weight, and when 6-10% total body weight has been lost. We will measure insulin sensitivity with an intravenous glucose tolerance test, and fasting levels of hormones that regulate food intake and insulin sensitivity, such as ghrelin, peptide YY (PYY), glucagon-like peptide 1 (GLP1) and leptin. Fat mass and skeletal muscle mass will be measured by dual photon absorptiometry (DXA). We will also measure the hormonal and thermic response to food with a liquid test meal and energy expenditure by indirect calorimetry. This measures how many calories are burned at rest and the in response to food. Subjects with diabetes will continue to be studied with the same protocol on an annual basis out to 5 years in order to determine the rate of remission of diabetes and the durability of this effect as subjects tend to regain some body weight over time.
Subjects with diabetes will also be followed every three months for the first year after the initial weight loss for HbA1c and fasting glucose levels. The results of this study may lead to new understanding about changes in insulin sensitivity, body composition and hormonal profile, as well as changes in energy expenditure with weight loss after bariatric surgery or with simple caloric restriction. With this greater understanding, new treatments for obesity and diabetes, that do not require surgery, may be developed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1: GBP non-diabetic | – | Procedure: Gastric bypassNon-diabetic subjects scheduled to receive gastric bypass |
| Group 2: BND non-diabetic | – | Procedure: Gastric bandingNon-diabetic subjects scheduled to receive gastric banding |
| Group 3: GBP diabetic | – | Procedure: Gastric bypassDiabetic subjects scheduled to receive gastric bypass |
| Group 4: VLCD diabetic | – | Behavioral: Very low calorie dietDiabetic subjects scheduled to receive very low calorie diet |
| Group 5: SG diabetic | – | Procedure: Sleeve gastrectomyDiabetic subjects scheduled to receive sleeve gastrectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited by physician referral and from outpatient obesity, bariatric surgical clinics and endocrinology clinics at Columbia University Medical Center as well as from the Medical Center Community and metropolitan area via IRB-approved flyers and internet postings. Subjects will also be recruited from the following website: www.craigslist.com using the same posting format of the IRB-approved flyers.
Key inclusion criteria (6 listed)
- Non-diabetic obese (BMI > 30) adult men and women between the ages of 18 and 75 scheduled to undergo
- Type 2 diabetes (HbA1c 6-12%) adult men and women between the ages of 18 and 75 scheduled to undergo gastric bypass.
- Type 2 diabetes (HbA1c 6-12%) adult men and women between the ages of 18 and 65 for weight reduction with a very low caloric diet (VLCD).
- Type 2 diabetes mellitus scheduled to undergo sleeve gastrectomy (SG).
Key exclusion criteria (12 listed)
- Pregnancy.
- Age > 75 for surgery groups; Age > 65 for VLCD group.
- Treatment with glucocorticoids, anti-depressants, anti-psychotics, neuroleptics, weight loss medications, experimental medication.
- Greater than a 5% change in total body weight in the 90 days prior to the study.
- History of untreated gallstones; hepatic or renal insufficiency, abnormal thyroid stimulating hormone (TSH).
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 |
|---|---|---|
| Gastric bypassAlso: GBPNOTE: the surgery is not paid for by the study | Procedure or surgery | Group 1: GBP non-diabetic, Group 3: GBP diabetic |
| Gastric bandingAlso: BNDNOTE: the surgery is not paid for by the study | Procedure or surgery | Group 2: BND non-diabetic |
| Sleeve gastrectomyAlso: SGNOTE: the surgery is not paid for by the study | Procedure or surgery | Group 5: SG diabetic |
| Very low calorie dietAlso: VLCDWeight loss with calorie restricted liquid diet. Subject will be asked to stay in our in-patient research unit for 2-3 weeks and consume only those foods supplied by our bionutrition unit. Expected weight loss should be between 7-10% of body weight. Subjects will receive the diet at no cost and will be compensated for their time. | Behavioural | Group 4: VLCD diabetic |
Primary outcome
Change in Insulin Sensitivity
Time frame: 2-8 weeks
Measured by frequently sampled intravenous glucose tolerance test (FSIVGTT)
2 secondary outcomes
Change in Body Composition
Time frame: 2-8 weeks
Change in Resting Energy Expenditure
Time frame: Up to 4 hrs post-meal
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 19 Sep 2019.
- Derived from this study: PubMed 23610060Jackness C, Karmally W, Febres G, Conwell IM, Ahmed L, Bessler M, McMahon DJ, Korner J. Very low-calorie diet mimics the early beneficial effect of Roux-en-Y gastric bypass on insulin sensitivity and beta-cell Function in type 2 diabetic patients. Diabetes. 2013 Sep;62(9):3027-32. doi: 10.2337/db12-1762. Epub 2013 Apr 22.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Obesity and Type 2 Diabetes Mellitus, 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 6 inclusion and 12 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 19 Sep 2019. 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 Insulin Sensitivity (time frame: 2-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00627484, which also lists 1 linked publication.
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 19 Sep 2019.