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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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Observational studies suggest that bariatric surgery is the most effective intervention for weight loss. Comparative effectiveness of Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) demonstrate that RYGB is significantly superior to SG in terms of weight loss and glycemic control. Both RYGB and SG increase GLP-1 concentrations which directly affect B-cell function. Data has shown that the postprandial rise in GLP-1 might affect feeding behavior after RYGB and to a lesser extent SG, where the increase in GLP-1 is less marked. In this study the investigators propose to randomize subjects undergoing SG to receive either placebo or Liraglutide, a GLP-1 receptor agonist, to compare weight loss and CV risk factors.
A total of 75, non diabetic adults, scheduled for bariatric surgery at Mayo Clinic Rochester, will be enrolled. Of these, 25 will be scheduled for Roux-en-Y Gastric Bypass surgery (RYGB), while the remainder (50) will be scheduled for Sleeve Gastrectomy (SG). The study team will play no role in assignment of the surgical procedure. Following surgery, at month 3, subjects undergoing SG will be randomized to either Saxenda or placebo, subcutaneously once daily. Subjects randomized to Saxenda or placebo will take for the duration of the study (33 months). Follow up study visits for all subjects will be timed to coincide with the standard clinical follow up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleeve Gastrectomy Placebo | Placebo Comparator | Subjects undergoing Sleeve Gastrectomy (SG) will be randomized 1:1 at the time of 3 month visit after bariatric surgery. |
|
| Sleeve Gastrectomy Saxenda | Active Comparator | Subjects undergoing Sleeve Gastrectomy (SG) will be randomized 1:1 at the time of 3 month visit after bariatric surgery. |
|
| RYGB | Sham Comparator | Twenty five subjects will be recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxenda | Drug | Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects will be recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will be randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study (33 months). After undergoing surgery, study visits will be timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Subjects calculated weight in kilograms | baseline and 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Systolic blood pressure (top number of blood pressure reading) | baseline and 36 months |
| Diastolic Blood Pressure | Diastolic blood pressure (bottom number of blood pressure reading) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Vella | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sleeve Gastrectomy Saxenda | Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery. Saxenda: Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will were randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36. |
| FG001 | Sleeve Gastrectomy Placebo | Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery. Placebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36. |
| FG002 | Roux-en-Y Gastric (RYGB) | Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery. RYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sleeve Gastrectomy Saxenda | Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery. Saxenda: Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will were randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight | Subjects calculated weight in kilograms | Data was not collected nor analyzed for eight subjects in the Sleeve Gastrectomy Saxenda arm. Data was not collected nor analyzed for seven subjects in the Sleeve Gastrectomy Placebo arm. Data was not collected nor analyzed for thirteen subjects in the Roux-en-Y Gastric (RYGB). | Posted | Mean | Standard Error | kilograms | baseline and 36 months |
|
Adverse Events were collected from baseline to end of study, approximately 36 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sleeve Gastrectomy Saxenda | Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery. Saxenda: Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will were randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hgb < 11.5 g/dL | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adrian Vella, M.D. | Mayo Clinic | 507-266-1387 | vella.adrian@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2023 | Sep 24, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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Double-blind design.
|
|
| Placebos | Drug | Subjects will be recruited and screened prior to undergoing bariatric surgery.Subjects undergoing SG will be randomized 1:1 at months 3 post surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study (33 months). After undergoing surgery, study visits will be timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36. |
|
|
| RYGB | Procedure | Subjects will be recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits will be timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36. |
|
| baseline and 36 months |
| Low-density Lipoprotein (LDL) | LDL's carry cholesterol through the bloodstream. LDL is called bad cholesterol because high amounts can form plaques in the blood vessels, increasing risk for heart disease. Adult normal range is less than 100 mg/dL. | baseline and 36 months |
| BG001 | Sleeve Gastrectomy Placebo | Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery. Placebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36. |
| BG002 | Roux-en-Y Gastric (RYGB) | Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery. RYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Sleeve Gastrectomy Placebo | Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery. Placebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36. |
| OG002 | Roux-en-Y Gastric (RYGB) | Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery. RYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36. |
|
|
| Secondary | Systolic Blood Pressure | Systolic blood pressure (top number of blood pressure reading) | Data was not collected nor analyzed for eight subjects in the Sleeve Gastrectomy Saxenda arm. Data was not collected nor analyzed for seven subjects in the Sleeve Gastrectomy Placebo arm. Data was not collected nor analyzed for thirteen subjects in the Roux-en-Y Gastric (RYGB). | Posted | Mean | Standard Error | Millimeters of Mercury | baseline and 36 months |
|
|
|
| Secondary | Diastolic Blood Pressure | Diastolic blood pressure (bottom number of blood pressure reading) | Data was not collected nor analyzed for eight subjects in the Sleeve Gastrectomy Saxenda arm. Data was not collected nor analyzed for seven subjects in the Sleeve Gastrectomy Placebo arm. Data was not collected nor analyzed for thirteen subjects in the Roux-en-Y Gastric (RYGB). | Posted | Mean | Standard Error | Millimeters of Mercury | baseline and 36 months |
|
|
|
| Secondary | Low-density Lipoprotein (LDL) | LDL's carry cholesterol through the bloodstream. LDL is called bad cholesterol because high amounts can form plaques in the blood vessels, increasing risk for heart disease. Adult normal range is less than 100 mg/dL. | Data was not collected nor analyzed for eight subjects in the Sleeve Gastrectomy Saxenda arm. Data was not collected nor analyzed for seven subjects in the Sleeve Gastrectomy Placebo arm. Data was not collected nor analyzed for thirteen subjects in the Roux-en-Y Gastric (RYGB). | Posted | Mean | Standard Error | mg/dL | baseline and 36 months |
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| 2 |
| 12 |
| EG001 | Sleeve Gastrectomy Placebo | Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery. Placebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36. | 0 | 9 | 0 | 9 | 1 | 9 |
| EG002 | Roux-en-Y Gastric (RYGB) | Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery. RYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36. | 0 | 25 | 0 | 25 | 14 | 25 |
| Nausea | General disorders | Systematic Assessment |
|
| Vomiting | General disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| Male |
|
| 36 months |
|
|
| 36 months |
|
|
| 36 months |
|
|