ObesityNCT00535600
Effects of Bariatric Surgery on Insulin
An observational study of Obesity and Bariatric Surgery, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
This study, conducted at the NIH Clinical Research Unit (CRU) at the Phoenix Indian Medical Center, will compare the effects of two methods of bariatric surgery, the adjustable BAND and Roux-en-Y gastric bypass, on insulin. Bariatric surgery is a treatment for achieving and maintaining weight loss. Read more about this study
- Who is it for?
- Ages 18 to 96 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Bariatric Surgery, Gastric Bypass
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2007to 19 Mar 2014
- 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 96 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must initially qualify for bariatric surgery according to current NIH guidelines, which require the presence of either morbid obesity alone (BMI greater than 40 kg/m(2)) or a BMI greater than 35 kg/m(2) along with at least 2 other co-morbidities.
- Patients with conditions such as sleep apnea, mild steatohepatitis, GERD, asthma (not requiring oral steroids) and osteoarthritis can be considered for participation.
- Subject with undiagnosed diabetes (2-h glucose greater than 200 mg/dl during initial screening OGTT) will be included in the IGR group ONLY IF BOTH fasting plasma glucose is less than 126 mg/dl and HbA1c is less than 7 percent, suggesting early T2DM.
- Subjects must be at least 18 years of age and less than 150 kg body weight.
- Males and females of all ethnic minorities will be included.
Who cannot join
- Because of the indications for bariatric surgery, many potential subjects will have underlying co-morbidities associated with obesity. For this protocol, subjects will be excluded for the following:
- Current smoking
- Previously diagnosed diabetes
- Other endocrine disorders, such as Cushing's disease, pituitary disorders, and thyroid disease
- Significant hepatic or renal disease (ALT and AST greater than 3-fold above upper limit of normal range, cirrhosis, active hepatitis B or C, serum creatinine greater than 1.5 mg/dl or presence of protein in urine dipstick)
- Active tuberculosis (self-report)
Show all 15Show fewer
- Major pulmonary disorders including physician diagnosed chronic obstructive pulmonary diseases other than obstructive sleep apnea
- Cardiovascular diseases, including coronary heart disease, heart failure, arrhythmias, and peripheral artery disease
- Hypertension (according to the World Health Organization diagnostic criteria), treated or uncontrolled
- Gastrointestinal disease, including inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active)
- Central nervous system disease, including previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders
- Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis
- Psychiatric conditions or behavior or current alcohol or illicit drug use that would be incompatible with safe and successful participation in this study
- Recent use (within 30 days) of anorexiant medications, antibiotics, contraceptives or fertility drugs or recent use (within 5 days) of anti inflammatory agents
- Pregnancy or breastfeeding (to avoid radiation exposure to fetus or nursing infant)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Bariatric Surgery on Changes in Insulin Secretion and Insulin Action
This study, conducted at the NIH Clinical Research Unit (CRU) at the Phoenix Indian Medical Center, will compare the effects of two methods of bariatric surgery, the adjustable BAND and Roux-en-Y gastric bypass, on insulin. Bariatric surgery is a treatment for achieving and maintaining weight loss. The study will look at how this surgery might improve how insulin (a hormone important for regulating blood sugar levels) is made and works in the body and the possible role of changes in other hormones produced by the gut (stomach and intestines).
People between 18 and 50 years of age who are scheduled to have either laparoscopic adjustable BAND or Roux-en-Y gastric bypass surgery may be eligible for this study. Candidates are screened about 4 to 6 weeks before their surgery with a medical history, blood tests and an oral glucose tolerance test for diabetes.
Read more
Participants spend 4 days at the CRU or 2 days overnight and an out-patient visit approximately 4 to 6 weeks before their surgery and again 3 to 6 weeks after their surgery. They return for a 4-6 hour visit at the CRU at 6 months, 1 and 2 years after surgery and for half-day outpatient visits at 3, 4 and 5 years after surgery for the following procedures:
- Blood and urine tests, including a pregnancy test for women. (4-day and 2-day admissions and years, 3, 4 and 5)
- DEXA, an x-ray scan to determine body fat content. (4-day and 2-day admissions and years, 3, 4 and 5)
- MRI scan to measure fat tissue in the abdomen. (4-day and 2-day admissions and years, 3, 4 and 5)
- Intravenous (I.V.) glucose tolerance test for risk of obesity and diabetes. A sugar solution is given through a needle in a vein of one arm and blood samples are drawn through another needle in a vein in the other arm. (4-day admissions)
- Meal test to measure blood sugar and insulin and gut hormone levels after a meal. After an I.V. line is placed in an arm vein, the subject eats breakfast over 20 minutes. Blood samples are collected halfway through the meal, at the end of the meal, and at 15, 30, 60, 90, 120 and 180 minutes after completing the meal. Subjects fill out questionnaires on feelings of hunger and fullness before, during and after the meal test. (4-day and 2-day admissions)
- Glucose clamp test to measure the effect on the body of insulin given through a vein. An I.V line is placed in a vein in the arm and in a vein of the hand on the other side of the body. While insulin is infused through one I.V., blood sugar levels are checked every 5 minutes and a sugar solution is given into a vein as needed. A radioactive sugar is also infused very slowly over 4 hours to determine how much sugar the body produces by itself. (4-day admissions)
Read the detailed description
Bariatric surgery is a treatment for obesity that, in many cases, also improves fasting blood sugar levels even in patients with type 2 diabetes (T2DM) - within days or weeks after surgery . Both inability to use insulin (insulin resistance) and inability to make enough insulin when needed (impaired insulin secretion) must be present for T2DM to occur, and both have been reported to improve after bariatric surgery. It is generally thought that the immediate improvement in blood sugar levels, including remission of T2DM or "prediabetes" in many patients, following bariatric surgery is due to the markedly reduced intake of calories. However, it is not known why blood sugar levels before and after meals tend to improve earlier and to a greater extent in patients who have a Roux en-Y gastric bypass (RYGB) procedure than in patients who have either the adjustable gastric banding (BAND) or sleeve gastrectomy (SG) procedure. It has been proposed that the surgical alteration of the gut and subsequent re-routing of food that occurs with RYGB procedure results in unique changes in how the gut and pancreas (the organ that secretes insulin) respond to food and that these changes are also related to improved insulin resistance and/or secretion.
The purpose of this protocol is to study, before and after surgery, volunteers who either have normal or impaired ("pre-diabetic") blood sugar regulation and who have been approved to undergo either elective RYGBP, BAND or SG bariatric surgery (n=16 each per surgery group, total = 48 individuals with normal blood sugars; n= 10 each per surgery group, total = 30 individuals with prediabetes). The primary aims are to compare the early effects of the BAND, SG and RYGBP procedures on: a) the ability to maintain blood sugar levels, b) how much insulin is made (secretion) and works (insulin action) in the body, and c) responses of gut and pancreas hormones to a meal test before any significant weight loss occurs after surgery. To achieve these goals, we initially will screen volunteers at the NIH Clinical Research Unit in Phoenix approximately 4-6 weeks prior to surgery (1-day outpatient visit) to determine oral glucose tolerance status (OGTT). Within 3 weeks (1-4 weeks prior to surgery), subjects will then be admitted (4-day in-patient stay) or a 2 day overnight stay and an outpatient (4-6 hour) visit to measure weight, body fatness (DXA scan), waist circumference, insulin resistance, insulin secretion, fasting blood sugar and hemoglobin A1c (HbA1c; a substance that indicates how well the body keeps overall blood sugar levels in a normal range), and plasma hormone responses of the gut and pancreas to a standard meal test. These measurements will be repeated at 3-6 weeks following surgery.
Secondary aims are to: 1) compare long-term effects (up to 5 years) of BAND, SG or RYGBP surgery on fasting blood sugar and HbA1c levels, 2) determine if these levels are related to the responses of gut and pancreas hormones during a meal test, and 3) determine whether pre-op or early post-op measures of insulin secretion, insulin action, or responses of gut and pancreas hormones to a meal can predict long-term levels of fasting blood sugar and HbA1c after accounting for changes in weight or body fat. To achieve these goals, subjects will return to the NIH CRU (out-patient, 4-6 hour visit) at 6, 12, and 24 months after surgery to have repeat measurements of body weight, fatness (DXA, non-contrast MRI of waist and thigh), waist circumference, fasting blood sugar and HbA1c levels and the gut and pancreatic hormone responses to a meal test. Thereafter, subjects will have annual outpatient measurements of body weight, body fat and fasting blood sugar and HbA1c levels at 3, 4 and 5 years after surgery.
- Conditions
- Obesity, Bariatric Surgery, Gastric Bypass, Weight Loss, Hyperglycemia
- Keywords
- Bariatric Surgery, Insulin Action, Insulin Secretion, Insulin Resistance, Gut Hormones, Obesity
- Medical subject headings
- Obesity, Weight Loss, Hyperglycemia, Insulin Resistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study start21 Sep 2007
- Study completion19 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Joy C Bunt, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535600
- Sponsor's protocol ID
- 999907226
- Other IDs
- 07-DK-N226
- Status last verified
- 19 Mar 2014
- First submitted
- 25 Sep 2007
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.
PubMed 15616203Pontiroli AE, Folli F, Paganelli M, Micheletto G, Pizzocri P, Vedani P, Luisi F, Perego L, Morabito A, Bressani Doldi S. Laparoscopic gastric banding prevents type 2 diabetes and arterial hypertension and induces their remission in morbid obesity: a 4-year case-controlled study. Diabetes Care. 2005 Nov;28(11):2703-9. doi: 10.2337/diacare.28.11.2703.
PubMed 16249543Ferchak CV, Meneghini LF. Obesity, bariatric surgery and type 2 diabetes--a systematic review. Diabetes Metab Res Rev. 2004 Nov-Dec;20(6):438-45. doi: 10.1002/dmrr.507.
PubMed 15386803
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bariatric Surgery on Changes in Insulin Secretion and Insulin Action
- ClinicalTrials.gov ID
- NCT00535600
- Acronym / sponsor ID
- 999907226
- Conditions
- Obesity, Bariatric Surgery, Gastric Bypass, Weight Loss, Hyperglycemia
- Keywords
- Bariatric Surgery, Insulin Action, Insulin Secretion, Insulin Resistance, Gut Hormones, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 21 Sep 2007
- Study completion
- 19 Mar 2014
- First posted
- 26 Sep 2007 (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, conducted at the NIH Clinical Research Unit (CRU) at the Phoenix Indian Medical Center, will compare the effects of two methods of bariatric surgery, the adjustable BAND and Roux-en-Y gastric bypass, on insulin. Bariatric surgery is a treatment for achieving and maintaining weight loss. The study will look at how this surgery might improve how insulin (a hormone important for regulating blood sugar levels) is made and works in the body and the possible role of changes in other hormones produced by the gut (stomach and intestines).
People between 18 and 50 years of age who are scheduled to have either laparoscopic adjustable BAND or Roux-en-Y gastric bypass surgery may be eligible for this study. Candidates are screened about 4 to 6 weeks before their surgery with a medical history, blood tests and an oral glucose tolerance test for diabetes.
Participants spend 4 days at the CRU or 2 days overnight and an out-patient visit approximately 4 to 6 weeks before their surgery and again 3 to 6 weeks after their surgery. They return for a 4-6 hour visit at the CRU at 6 months, 1 and 2 years after surgery and for half-day outpatient visits at 3, 4 and 5 years after surgery for the following procedures:
- Blood and urine tests, including a pregnancy test for women. (4-day and 2-day admissions and years, 3, 4 and 5)
- DEXA, an x-ray scan to determine body fat content. (4-day and 2-day admissions and years, 3, 4 and 5)
- MRI scan to measure fat tissue in the abdomen. (4-day and 2-day admissions and years, 3, 4 and 5)
- Intravenous (I.V.) glucose tolerance test for risk of obesity and diabetes. A sugar solution is given through a needle in a vein of one arm and blood samples are drawn through another needle in a vein in the other arm. (4-day admissions)
- Meal test to measure blood sugar and insulin and gut hormone levels after a meal. After an I.V. line is placed in an arm vein, the subject eats breakfast over 20 minutes. Blood samples are collected halfway through the meal, at the end of the meal, and at 15, 30, 60, 90, 120 and 180 minutes after completing the meal. Subjects fill out questionnaires on feelings of hunger and fullness before, during and after the meal test. (4-day and 2-day admissions)
- Glucose clamp test to measure the effect on the body of insulin given through a vein. An I.V line is placed in a vein in the arm and in a vein of the hand on the other side of the body. While insulin is infused through one I.V., blood sugar levels are checked every 5 minutes and a sugar solution is given into a vein as needed. A radioactive sugar is also infused very slowly over 4 hours to determine how much sugar the body produces by itself. (4-day admissions)
Detailed description
Bariatric surgery is a treatment for obesity that, in many cases, also improves fasting blood sugar levels even in patients with type 2 diabetes (T2DM) - within days or weeks after surgery . Both inability to use insulin (insulin resistance) and inability to make enough insulin when needed (impaired insulin secretion) must be present for T2DM to occur, and both have been reported to improve after bariatric surgery. It is generally thought that the immediate improvement in blood sugar levels, including remission of T2DM or "prediabetes" in many patients, following bariatric surgery is due to the markedly reduced intake of calories. However, it is not known why blood sugar levels before and after meals tend to improve earlier and to a greater extent in patients who have a Roux en-Y gastric bypass (RYGB) procedure than in patients who have either the adjustable gastric banding (BAND) or sleeve gastrectomy (SG) procedure. It has been proposed that the surgical alteration of the gut and subsequent re-routing of food that occurs with RYGB procedure results in unique changes in how the gut and pancreas (the organ that secretes insulin) respond to food and that these changes are also related to improved insulin resistance and/or secretion.
The purpose of this protocol is to study, before and after surgery, volunteers who either have normal or impaired ("pre-diabetic") blood sugar regulation and who have been approved to undergo either elective RYGBP, BAND or SG bariatric surgery (n=16 each per surgery group, total = 48 individuals with normal blood sugars; n= 10 each per surgery group, total = 30 individuals with prediabetes). The primary aims are to compare the early effects of the BAND, SG and RYGBP procedures on: a) the ability to maintain blood sugar levels, b) how much insulin is made (secretion) and works (insulin action) in the body, and c) responses of gut and pancreas hormones to a meal test before any significant weight loss occurs after surgery. To achieve these goals, we initially will screen volunteers at the NIH Clinical Research Unit in Phoenix approximately 4-6 weeks prior to surgery (1-day outpatient visit) to determine oral glucose tolerance status (OGTT). Within 3 weeks (1-4 weeks prior to surgery), subjects will then be admitted (4-day in-patient stay) or a 2 day overnight stay and an outpatient (4-6 hour) visit to measure weight, body fatness (DXA scan), waist circumference, insulin resistance, insulin secretion, fasting blood sugar and hemoglobin A1c (HbA1c; a substance that indicates how well the body keeps overall blood sugar levels in a normal range), and plasma hormone responses of the gut and pancreas to a standard meal test. These measurements will be repeated at 3-6 weeks following surgery.
Secondary aims are to: 1) compare long-term effects (up to 5 years) of BAND, SG or RYGBP surgery on fasting blood sugar and HbA1c levels, 2) determine if these levels are related to the responses of gut and pancreas hormones during a meal test, and 3) determine whether pre-op or early post-op measures of insulin secretion, insulin action, or responses of gut and pancreas hormones to a meal can predict long-term levels of fasting blood sugar and HbA1c after accounting for changes in weight or body fat. To achieve these goals, subjects will return to the NIH CRU (out-patient, 4-6 hour visit) at 6, 12, and 24 months after surgery to have repeat measurements of body weight, fatness (DXA, non-contrast MRI of waist and thigh), waist circumference, fasting blood sugar and HbA1c levels and the gut and pancreatic hormone responses to a meal test. Thereafter, subjects will have annual outpatient measurements of body weight, body fat and fasting blood sugar and HbA1c levels at 3, 4 and 5 years after surgery.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 96 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must initially qualify for bariatric surgery according to current NIH guidelines, which require the presence of either morbid obesity alone (BMI greater than 40 kg/m(2)) or a BMI greater than 35 kg/m(2) along with at least 2 other co-morbidities.
- Patients with conditions such as sleep apnea, mild steatohepatitis, GERD, asthma (not requiring oral steroids) and osteoarthritis can be considered for participation.
- Subject with undiagnosed diabetes (2-h glucose greater than 200 mg/dl during initial screening OGTT) will be included in the IGR group ONLY IF BOTH fasting plasma glucose is less than 126 mg/dl and HbA1c is less than 7 percent, suggesting early T2DM.
- Subjects must be at least 18 years of age and less than 150 kg body weight.
- Males and females of all ethnic minorities will be included.
Key exclusion criteria (15 listed)
- Because of the indications for bariatric surgery, many potential subjects will have underlying co-morbidities associated with obesity. For this protocol, subjects will be excluded for the following:
- Current smoking
- Previously diagnosed diabetes
- Other endocrine disorders, such as Cushing's disease, pituitary disorders, and thyroid disease
- Significant hepatic or renal disease (ALT and AST greater than 3-fold above upper limit of normal range, cirrhosis, active hepatitis B or C, serum creatinine greater than 1.5 mg/dl or presence of protein in urine dipstick)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 17 Dec 2019.
- Background: PubMed 15616203Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.
- Background: PubMed 16249543Pontiroli AE, Folli F, Paganelli M, Micheletto G, Pizzocri P, Vedani P, Luisi F, Perego L, Morabito A, Bressani Doldi S. Laparoscopic gastric banding prevents type 2 diabetes and arterial hypertension and induces their remission in morbid obesity: a 4-year case-controlled study. Diabetes Care. 2005 Nov;28(11):2703-9. doi: 10.2337/diacare.28.11.2703.
- Background: PubMed 15386803Ferchak CV, Meneghini LF. Obesity, bariatric surgery and type 2 diabetes--a systematic review. Diabetes Metab Res Rev. 2004 Nov-Dec;20(6):438-45. doi: 10.1002/dmrr.507.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Joy C Bunt, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 Bariatric Surgery, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 5 inclusion and 15 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 17 Dec 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00535600, which also lists 3 linked publications.
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 17 Dec 2019.