ObesityNCT00873405
Banded Sleeve Gastrectomy Versus Banded Ring Gastric Bypass in Morbidly Obese Patients
A study testing Silastic® ring sleeve gastrectomy and Silastic® ring gastric bypass in people with Obesity, run by Federal University of Espirito Santo at 1 site in Brazil.
Trial summary
Obesity is a multifactorial disease that affects millions of people worldwide. It is the main independent risk factor for developing type 2 diabetes mellitus (T2DM). Most patients with T2DM and glucose intolerance (GI) are overweight, a condition known as diabesity. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Silastic® ring sleeve gastrectomy and Silastic® ring gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2006to Jun 2009
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female patients aged 20-60 years
- BMI 40-45 (inclusive)
- agreed on giving written informed consent
Who cannot join
- secondary obesity
- alcohol or drug use
- severe psychiatric disorder
- binge-eating of sweets
- previous stomach or bowel surgery
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Cassiano Antonio Moraes University Hospital, Federal University of Espírito Santo
Vitória, Espírito Santo, 29040-091
About this study
Official title: Banded Sleeve Gastrectomy Versus Banded Ring Gastric Bypass in Morbidly Obese Patients: a Prospective Controlled Trial.
Obesity is a multifactorial disease that affects millions of people worldwide. It is the main independent risk factor for developing type 2 diabetes mellitus (T2DM). Most patients with T2DM and glucose intolerance (GI) are overweight, a condition known as diabesity. In patients with the most severe form of obesity, i.e., morbid obesity, the likelihood of developing diseases associated with obesity is increased.
The investigators currently know that bariatric surgery provides sustained weight loss and well-documented remission of T2DM. Patients who undergo bariatric surgery show long-term reduced mortality from coronary artery disease, cancer and diabetes; 136 lives are saved per 10,000 surgical procedures performed. Bariatric surgery is a relatively safe procedure that is becoming increasingly well-accepted; in 2007, approximately 170,000 bariatric procedures were performed in the USA. Currently, bariatric surgery is the most effective choice of treatment of morbidly obese patients with diabetes.
Read more
The surgical procedures that are currently performed to treat morbid obesity are divided into two main groups: gastric restrictive procedures and combination procedures; the latter combine gastric restriction and malabsorption. The roux-en-Y gastric bypass (RYGB) is the combination procedure most frequently performed, whereas sleeve gastrectomy (SG) is an emerging restrictive procedure. SG can be performed as the first of a two-stage operation in patients at high risk of death, or as a definitive surgical procedure. It has shown good results with regard to weight loss and glycemic control in various studies. The potential advantages of SG include lower probability of vitamin and mineral deficiencies because this procedure has no malabsorptive component; access to the entire intestinal tract; no need for a subcutaneous access port or adjustments; absence of dumping syndrome and lower probability of intestinal obstruction. In addition, SG can be performed in patients who have inflammatory bowel disease or who have undergone bowel surgery, and it can be easily converted into RYGB. Both SG and RYGB can be performed with or without the placement of a Silastic® ring.
The metabolic control achieved with bariatric procedures has been demonstrated and reproduced in various medical centers worldwide. Metabolic control can be achieved with gastric restrictive procedures such as vertical banded gastroplasty, adjustable gastric banding and, more recently, SG. However, it has been shown that glucose homeostasis is affected by various intestinal mechanisms observed exclusively in procedures that include a malabsorptive element, such as RYGB.
A systematic review of 22,094 cases of morbidly obese patients submitted to bariatric surgery has shown that resolution of T2DM was achieved in 76.8% of the cases, improvement being achieved in 86% of cases. Among the criteria used to diagnose metabolic syndrome, fasting glucose levels are the first to return to normal in patients submitted to Silastic® ring gastric bypass (SRGB), a modification of the traditional RYGB which consists in adding a Silastic® ring to the gastric bypass operation. Normoglycemia after bariatric procedures, as well as diabesity itself, is multifactorial. Normoglycemia is observed as a result of dietary control, decreased plasma levels of ghrelin, weight loss and reduction of body fat, as well as of the release of gastrointestinal hormones that interfere with the function of pancreatic β cells (incretins).
The main purpose of this study was to compare the weight loss of morbidly obese patients submitted to either a Silastic® ring sleeve gastrectomy (SRSG) or an SRGB, as well as to compare the effects of both procedures on glucose homeostasis in morbidly obese patients.
- Conditions
- Obesity
- Being tested
- Silastic® ring sleeve gastrectomy, Silastic® ring gastric bypass
- Keywords
- Type 2 diabetes mellitus, Metabolic control, Bariatric Surgery, Weight Loss, Sleeve gastrectomy, BMI reduction, Waist circumference reduction, Percentage of excess BMI loss, Glucose homeostasis
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silastic® ring sleeve gastrectomyProcedure or surgery
Also called Sleeve gastrectomy
SRSG group: ligation of the vessels of the greater curvature of the body and fundus of stomach; resection of the fundus and part of the body of stomach using a linear stapler (80 mm, Tyco®) and a 32-Fr tube to calibrate the remaining stomach; placement of a 6.2 cm Silastic® ring around the stomach, 5.0 cm below the esophagogastric junction.
Silastic® ring gastric bypassProcedure or surgery
Also called gastric bypass
SRGB group: creation of a small, proximal gastric pouch using a linear stapler (80 mm, Tyco®) and a 32-Fr tube to calibrate the gastric pouch; creation of an intestinal loop of 150 cm and a biliopancreatic loop of 40 cm; placement of a 6.2 cm Silastic® ring around the stomach, 5.0 cm below the esophagogastric junction.
| Study group | Role | What they receive |
|---|---|---|
| SRSG | Active comparator | Silastic® ring sleeve gastrectomy (SRSG). Receives: Procedure: Silastic® ring sleeve gastrectomy |
| SRGB | Other | Silastic® ring gastric bypass. Receives: Procedure: Silastic® ring sleeve gastrectomy; Procedure: Silastic® ring gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss, BMI reduction and waist circumference reduction
Measured: 12 months
Secondary outcomes (1)
Glucose homeostasis, metabolic control.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startJun 2006
- Primary completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Espirito Santo
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of São Paulo
- Investigators
- Gustavo PS Miguel, Surgery Assistant Professor, Principal investigator, Federal University of Espírito Santo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873405
- Sponsor's protocol ID
- 049/06
- Status last verified
- Mar 2009
- First submitted
- 31 Mar 2009
- Last updated
- 1 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee CM, Cirangle PT, Jossart GH. Vertical gastrectomy for morbid obesity in 216 patients: report of two-year results. Surg Endosc. 2007 Oct;21(10):1810-6. doi: 10.1007/s00464-007-9276-y. Epub 2007 Mar 14.
PubMed 17356932Cottam D, Qureshi FG, Mattar SG, Sharma S, Holover S, Bonanomi G, Ramanathan R, Schauer P. Laparoscopic sleeve gastrectomy as an initial weight-loss procedure for high-risk patients with morbid obesity. Surg Endosc. 2006 Jun;20(6):859-63. doi: 10.1007/s00464-005-0134-5. Epub 2006 Apr 22.
PubMed 16738970Silecchia G, Boru C, Pecchia A, Rizzello M, Casella G, Leonetti F, Basso N. Effectiveness of laparoscopic sleeve gastrectomy (first stage of biliopancreatic diversion with duodenal switch) on co-morbidities in super-obese high-risk patients. Obes Surg. 2006 Sep;16(9):1138-44. doi: 10.1381/096089206778392275.
PubMed 16989696Baltasar A, Serra C, Perez N, Bou R, Bengochea M, Ferri L. Laparoscopic sleeve gastrectomy: a multi-purpose bariatric operation. Obes Surg. 2005 Sep;15(8):1124-8. doi: 10.1381/0960892055002248.
PubMed 16197783Moon Han S, Kim WW, Oh JH. Results of laparoscopic sleeve gastrectomy (LSG) at 1 year in morbidly obese Korean patients. Obes Surg. 2005 Nov-Dec;15(10):1469-75. doi: 10.1381/096089205774859227.
PubMed 16354529Vidal J, Ibarzabal A, Romero F, Delgado S, Momblan D, Flores L, Lacy A. Type 2 diabetes mellitus and the metabolic syndrome following sleeve gastrectomy in severely obese subjects. Obes Surg. 2008 Sep;18(9):1077-82. doi: 10.1007/s11695-008-9547-2. Epub 2008 Jun 3.
PubMed 18521701Fobi M. Why the Operation I Prefer is Silastic Ring Vertical Gastric Bypass. Obes Surg. 1991 Dec;1(4):423-426. doi: 10.1381/096089291765560854.
PubMed 10775946Buchwald H, Buchwald JN. Evolution of operative procedures for the management of morbid obesity 1950-2000. Obes Surg. 2002 Oct;12(5):705-17. doi: 10.1381/096089202321019747.
PubMed 12448398Adams TD, Gress RE, Smith SC, Halverson RC, Simper SC, Rosamond WD, Lamonte MJ, Stroup AM, Hunt SC. Long-term mortality after gastric bypass surgery. N Engl J Med. 2007 Aug 23;357(8):753-61. doi: 10.1056/NEJMoa066603.
PubMed 17715409Sjostrom L, Narbro K, Sjostrom CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. doi: 10.1056/NEJMoa066254.
PubMed 17715408Must A, Spadano J, Coakley EH, Field AE, Colditz G, Dietz WH. The disease burden associated with overweight and obesity. JAMA. 1999 Oct 27;282(16):1523-9. doi: 10.1001/jama.282.16.1523.
PubMed 10546691Cummings DE, Overduin J, Foster-Schubert KE. Gastric bypass for obesity: mechanisms of weight loss and diabetes resolution. J Clin Endocrinol Metab. 2004 Jun;89(6):2608-15. doi: 10.1210/jc.2004-0433. No abstract available.
PubMed 15181031Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
PubMed 15479938Langer FB, Reza Hoda MA, Bohdjalian A, Felberbauer FX, Zacherl J, Wenzl E, Schindler K, Luger A, Ludvik B, Prager G. Sleeve gastrectomy and gastric banding: effects on plasma ghrelin levels. Obes Surg. 2005 Aug;15(7):1024-9. doi: 10.1381/0960892054621125.
PubMed 16105401Nakazato M, Murakami N, Date Y, Kojima M, Matsuo H, Kangawa K, Matsukura S. A role for ghrelin in the central regulation of feeding. Nature. 2001 Jan 11;409(6817):194-8. doi: 10.1038/35051587.
PubMed 11196643
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Banded Sleeve Gastrectomy Versus Banded Ring Gastric Bypass in Morbidly Obese Patients: a Prospective Controlled Trial.
- ClinicalTrials.gov ID
- NCT00873405
- Acronym / sponsor ID
- 049/06
- Conditions
- Obesity
- Keywords
- Type 2 diabetes mellitus, Metabolic control, Bariatric Surgery, Weight Loss, Sleeve gastrectomy, BMI reduction, Waist circumference reduction, Percentage of excess BMI loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Federal University of Espirito SantoUniversity, hospital or other
- Collaborators
- Federal University of São Paulo
- Study start
- Jun 2006
- Primary completion
- Jun 2009 (estimated)
- First posted
- 1 Apr 2009 (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.
Obesity is a multifactorial disease that affects millions of people worldwide. It is the main independent risk factor for developing type 2 diabetes mellitus (T2DM). Most patients with T2DM and glucose intolerance (GI) are overweight, a condition known as diabesity. In patients with the most severe form of obesity, i.e., morbid obesity, the likelihood of developing diseases associated with obesity is increased.
The investigators currently know that bariatric surgery provides sustained weight loss and well-documented remission of T2DM. Patients who undergo bariatric surgery show long-term reduced mortality from coronary artery disease, cancer and diabetes; 136 lives are saved per 10,000 surgical procedures performed. Bariatric surgery is a relatively safe procedure that is becoming increasingly well-accepted; in 2007, approximately 170,000 bariatric procedures were performed in the USA. Currently, bariatric surgery is the most effective choice of treatment of morbidly obese patients with diabetes.
The surgical procedures that are currently performed to treat morbid obesity are divided into two main groups: gastric restrictive procedures and combination procedures; the latter combine gastric restriction and malabsorption. The roux-en-Y gastric bypass (RYGB) is the combination procedure most frequently performed, whereas sleeve gastrectomy (SG) is an emerging restrictive procedure. SG can be performed as the first of a two-stage operation in patients at high risk of death, or as a definitive surgical procedure. It has shown good results with regard to weight loss and glycemic control in various studies. The potential advantages of SG include lower probability of vitamin and mineral deficiencies because this procedure has no malabsorptive component; access to the entire intestinal tract; no need for a subcutaneous access port or adjustments; absence of dumping syndrome and lower probability of intestinal obstruction. In addition, SG can be performed in patients who have inflammatory bowel disease or who have undergone bowel surgery, and it can be easily converted into RYGB. Both SG and RYGB can be performed with or without the placement of a Silastic® ring.
The metabolic control achieved with bariatric procedures has been demonstrated and reproduced in various medical centers worldwide. Metabolic control can be achieved with gastric restrictive procedures such as vertical banded gastroplasty, adjustable gastric banding and, more recently, SG. However, it has been shown that glucose homeostasis is affected by various intestinal mechanisms observed exclusively in procedures that include a malabsorptive element, such as RYGB.
A systematic review of 22,094 cases of morbidly obese patients submitted to bariatric surgery has shown that resolution of T2DM was achieved in 76.8% of the cases, improvement being achieved in 86% of cases. Among the criteria used to diagnose metabolic syndrome, fasting glucose levels are the first to return to normal in patients submitted to Silastic® ring gastric bypass (SRGB), a modification of the traditional RYGB which consists in adding a Silastic® ring to the gastric bypass operation. Normoglycemia after bariatric procedures, as well as diabesity itself, is multifactorial. Normoglycemia is observed as a result of dietary control, decreased plasma levels of ghrelin, weight loss and reduction of body fat, as well as of the release of gastrointestinal hormones that interfere with the function of pancreatic β cells (incretins).
The main purpose of this study was to compare the weight loss of morbidly obese patients submitted to either a Silastic® ring sleeve gastrectomy (SRSG) or an SRGB, as well as to compare the effects of both procedures on glucose homeostasis in morbidly obese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRSG | Active comparator | Procedure: Silastic® ring sleeve gastrectomySilastic® ring sleeve gastrectomy (SRSG). |
| SRGB | Other | Procedure: Silastic® ring sleeve gastrectomy, Procedure: Silastic® ring gastric bypassSilastic® ring gastric bypass. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- female patients aged 20-60 years
- BMI 40-45 (inclusive)
- agreed on giving written informed consent
Key exclusion criteria (5 listed)
- secondary obesity
- alcohol or drug use
- severe psychiatric disorder
- binge-eating of sweets
- previous stomach or bowel surgery
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 |
|---|---|---|
| Silastic® ring sleeve gastrectomyAlso: Sleeve gastrectomySRSG group: ligation of the vessels of the greater curvature of the body and fundus of stomach; resection of the fundus and part of the body of stomach using a linear stapler (80 mm, Tyco®) and a 32-Fr tube to calibrate the remaining stomach; placement of a 6.2 cm Silastic® ring around the stomach, 5.0 cm below the esophagogastric junction. | Procedure or surgery | SRGB, SRSG |
| Silastic® ring gastric bypassAlso: gastric bypassSRGB group: creation of a small, proximal gastric pouch using a linear stapler (80 mm, Tyco®) and a 32-Fr tube to calibrate the gastric pouch; creation of an intestinal loop of 150 cm and a biliopancreatic loop of 40 cm; placement of a 6.2 cm Silastic® ring around the stomach, 5.0 cm below the esophagogastric junction. | Procedure or surgery | SRGB |
Primary outcome
Weight loss, BMI reduction and waist circumference reduction
Time frame: 12 months
1 secondary outcome
Glucose homeostasis, metabolic control.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2009.
- Background: PubMed 17356932Lee CM, Cirangle PT, Jossart GH. Vertical gastrectomy for morbid obesity in 216 patients: report of two-year results. Surg Endosc. 2007 Oct;21(10):1810-6. doi: 10.1007/s00464-007-9276-y. Epub 2007 Mar 14.
- Background: PubMed 16738970Cottam D, Qureshi FG, Mattar SG, Sharma S, Holover S, Bonanomi G, Ramanathan R, Schauer P. Laparoscopic sleeve gastrectomy as an initial weight-loss procedure for high-risk patients with morbid obesity. Surg Endosc. 2006 Jun;20(6):859-63. doi: 10.1007/s00464-005-0134-5. Epub 2006 Apr 22.
- Background: PubMed 16989696Silecchia G, Boru C, Pecchia A, Rizzello M, Casella G, Leonetti F, Basso N. Effectiveness of laparoscopic sleeve gastrectomy (first stage of biliopancreatic diversion with duodenal switch) on co-morbidities in super-obese high-risk patients. Obes Surg. 2006 Sep;16(9):1138-44. doi: 10.1381/096089206778392275.
- Background: PubMed 16197783Baltasar A, Serra C, Perez N, Bou R, Bengochea M, Ferri L. Laparoscopic sleeve gastrectomy: a multi-purpose bariatric operation. Obes Surg. 2005 Sep;15(8):1124-8. doi: 10.1381/0960892055002248.
- Background: PubMed 16354529Moon Han S, Kim WW, Oh JH. Results of laparoscopic sleeve gastrectomy (LSG) at 1 year in morbidly obese Korean patients. Obes Surg. 2005 Nov-Dec;15(10):1469-75. doi: 10.1381/096089205774859227.
- Background: PubMed 18521701Vidal J, Ibarzabal A, Romero F, Delgado S, Momblan D, Flores L, Lacy A. Type 2 diabetes mellitus and the metabolic syndrome following sleeve gastrectomy in severely obese subjects. Obes Surg. 2008 Sep;18(9):1077-82. doi: 10.1007/s11695-008-9547-2. Epub 2008 Jun 3.
- Background: PubMed 10775946Fobi M. Why the Operation I Prefer is Silastic Ring Vertical Gastric Bypass. Obes Surg. 1991 Dec;1(4):423-426. doi: 10.1381/096089291765560854.
- Background: PubMed 12448398Buchwald H, Buchwald JN. Evolution of operative procedures for the management of morbid obesity 1950-2000. Obes Surg. 2002 Oct;12(5):705-17. doi: 10.1381/096089202321019747.
- Background: PubMed 17715409Adams TD, Gress RE, Smith SC, Halverson RC, Simper SC, Rosamond WD, Lamonte MJ, Stroup AM, Hunt SC. Long-term mortality after gastric bypass surgery. N Engl J Med. 2007 Aug 23;357(8):753-61. doi: 10.1056/NEJMoa066603.
- Background: PubMed 17715408Sjostrom L, Narbro K, Sjostrom CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. doi: 10.1056/NEJMoa066254.
- Background: PubMed 10546691Must A, Spadano J, Coakley EH, Field AE, Colditz G, Dietz WH. The disease burden associated with overweight and obesity. JAMA. 1999 Oct 27;282(16):1523-9. doi: 10.1001/jama.282.16.1523.
- Background: PubMed 15181031Cummings DE, Overduin J, Foster-Schubert KE. Gastric bypass for obesity: mechanisms of weight loss and diabetes resolution. J Clin Endocrinol Metab. 2004 Jun;89(6):2608-15. doi: 10.1210/jc.2004-0433. No abstract available.
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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.
Gustavo PS Miguel, Surgery Assistant Professor principal investigator
Federal University of Espírito Santo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silastic® ring sleeve gastrectomy and Silastic® ring gastric bypass in people with Obesity, run by Federal University of Espirito Santo at 1 site in Brazil.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Apr 2009. 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 Brazil. 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?
Results are not available in the source record.
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?
Weight loss, BMI reduction and waist circumference reduction (time frame: 12 months). 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 NCT00873405, which also lists 19 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 1 Apr 2009.