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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK094430 | U.S. NIH Grant/Contract | View source | |
| IIT - 000395 | Other Grant/Funding Number | Allergan Corporation |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Weight loss achieved through gastric banding will be superior to treatment with metformin in preserving or restoring pancreatic beta cell function in people with prediabetes or mild type 2 diabetes.
BetaFat is a 2-arm, unblinded study to compare gastric banding to treatment with metformin over a 24-month period in moderately obese adults with pre- or mild type 2 diabetes. The primary outcome will be change in β-cell compensation for insulin resistance, which the investigators will compare between groups. Secondary analyses will include other potential markers of β-cell health and potential mediators of treatment-specific effects. The main focus will be on mediators related to obesity. Clinically, the project will serve as a test of concept for use of gastric banding relatively early in the spectrum of obesity and β-cell disease. Biologically, the results will provide crucial information on potential mediators of β-cell failure and its arrest or reversal in the context of obesity. Those mediators will guide the development of more effective treatment and monitoring for the β-cell disease that causes type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metformin | Active Comparator | subjects receiving metformin |
|
| gastric banding | Experimental | subjects receiving LAP-BAND |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | metformin 1000 mg bid |
| |
| gastric banding |
| Measure | Description | Time Frame |
|---|---|---|
| Steady State Beta Cell Compensation | mean plasma C-peptide concentration during clamp steady state, adjusted for mean clamp insulin sensitivity | 24 months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Glycemia | fasting and 2-hour OGTT glucose levels | 24 months |
| Glycemia | HbA1C | 24 months |
Inclusion Criteria:
Exclusion Criteria:
Contraindications to LapBand(see Appendix 1)
Contraindication to MRI (claustrophobia; permanent metal objects such as pacemakers, prostheses, aneurysm clips)
Underlying disease(s) likely to (a) limit life span to less than study duration and/or (b) increase risk of intervention outside of the study and/or (c) limit ability to participate in outcomes assessment and/or (d) limit participation
An underlying disease known to have important effects on glucose metabolism
Active infections
Renal disease (serum creatinine ≥1.4 mg/dl for men; ≥1.3 mg/dl for women) or serum potassium abnormality (<3.4 or >5.5 mmol/l)
Anemia (hemoglobin <11g/dl in women, <12 g/dl in men) or known coagulopathy
Cardiovascular disease, including uncontrolled hypertension and symptomatic congestive heart failure. Participants must be able to safely tolerate administration of fluid/volume challenges during clamp studies.
Serum AST >3 times upper limit of normal in local clinical lab
Excessive alcohol intake
Suboptimally treated thyroid disease
Conditions or behaviors likely to affect the conduct of the study
additional conditions may serve as criteria for exclusion at the discretion of the local site
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| Name | Affiliation | Role |
|---|---|---|
| Thomas A Buchanan, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 91011 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24194506 | Background | RISE Consortium. Restoring Insulin Secretion (RISE): design of studies of beta-cell preservation in prediabetes and early type 2 diabetes across the life span. Diabetes Care. 2014;37(3):780-8. doi: 10.2337/dc13-1879. Epub 2013 Nov 5. | |
| 30282699 | Result | Xiang AH, Trigo E, Martinez M, Katkhouda N, Beale E, Wang X, Wu J, Chow T, Montgomery C, Nayak KS, Hendee F, Buchanan TA; RISE Consortium; RISE Collaborators. Impact of Gastric Banding Versus Metformin on beta-Cell Function in Adults With Impaired Glucose Tolerance or Mild Type 2 Diabetes. Diabetes Care. 2018 Dec;41(12):2544-2551. doi: 10.2337/dc18-1662. Epub 2018 Oct 3. |
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Five participants randomized to metformin and six participants randomized to gastric banding refused to initiate treatment
Recruited from Kaiser Permanente Southern California
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| ID | Title | Description |
|---|---|---|
| FG000 | Metformin | subjects receiving metformin Metformin: metformin 1000 mg bid |
| FG001 | Gastric Banding | subjects receiving LAP-BAND gastric banding: LAP-BAND |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Metformin | subjects receiving metformin Metformin: metformin 1000 mg bid |
| BG001 | Gastric Banding | subjects receiving LAP-BAND gastric banding: LAP-BAND |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Steady State Beta Cell Compensation | mean plasma C-peptide concentration during clamp steady state, adjusted for mean clamp insulin sensitivity | Participants completing 24-month hyperglycemic clamp | Posted | Geometric Mean | 95% Confidence Interval | (nmol/L) adjusted for M/I | 24 months |
|
24 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 | Metformin | subjects receiving metformin Metformin: metformin 1000 mg bid | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastric band slippage requiring removal | Gastrointestinal disorders | Systematic Assessment | gastric band slippage requireing removal |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Port revision | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Buchanan | University or Southern California | 3234794319 | buchanan@usc.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 | Aug 28, 2016 | Aug 28, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 5, 2018 | Aug 28, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Device |
LAP-BAND |
|
| 29941497 | Result | RISE Consortium. Metabolic Contrasts Between Youth and Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes: I. Observations Using the Hyperglycemic Clamp. Diabetes Care. 2018 Aug;41(8):1696-1706. doi: 10.2337/dc18-0244. Epub 2018 Jun 25. |
| 36938582 | Derived | Tjaden AH, Edelstein SL, Arslanian S, Barengolts E, Caprio S, Cree-Green M, Lteif A, Mather KJ, Savoye M, Xiang AH, Kahn SE. Reproducibility of Glycemic Measures Among Dysglycemic Youth and Adults in the RISE Study. J Clin Endocrinol Metab. 2023 Sep 18;108(10):e1125-e1133. doi: 10.1210/clinem/dgad135. |
| 35894078 | Derived | Utzschneider KM, Ehrmann DA, Arslanian SA, Barengolts E, Buchanan TA, Caprio S, Edelstein SL, Hannon TS, Kahn SE, Kozedub A, Mather KJ, Nadeau KJ, Sam S, Tripputi M, Xiang AH, El Ghormli L; RISE Consortium. Weight loss and beta-cell responses following gastric banding or pharmacotherapy in adults with impaired glucose tolerance or type 2 diabetes: a randomized trial. Obesity (Silver Spring). 2022 Aug;30(8):1579-1588. doi: 10.1002/oby.23475. |
| 34135015 | Derived | Kahn SE, Edelstein SL, Arslanian SA, Barengolts E, Caprio S, Ehrmann DA, Hannon TS, Marcovina S, Mather KJ, Nadeau KJ, Utzschneider KM, Xiang AH, Buchanan TA; RISE Consortium; Rise Consortium Investigators:. Effect of Medical and Surgical Interventions on alpha-Cell Function in Dysglycemic Youth and Adults in the RISE Study. Diabetes Care. 2021 Sep;44(9):1948-1960. doi: 10.2337/dc21-0461. Epub 2021 Jun 16. |
| 34131047 | Derived | Kahn SE, Mather KJ, Arslanian SA, Barengolts E, Buchanan TA, Caprio S, Ehrmann DA, Hannon TS, Marcovina S, Nadeau KJ, Utzschneider KM, Xiang AH, Edelstein SL; RISE Consortium; Rise Consortium Investigators:. Hyperglucagonemia Does Not Explain the beta-Cell Hyperresponsiveness and Insulin Resistance in Dysglycemic Youth Compared With Adults: Lessons From the RISE Study. Diabetes Care. 2021 Sep;44(9):1961-1969. doi: 10.2337/dc21-0460. Epub 2021 Jun 15. |
| 33436401 | Derived | Arslanian SA, El Ghormli L, Kim JY, Tjaden AH, Barengolts E, Caprio S, Hannon TS, Mather KJ, Nadeau KJ, Utzschneider KM, Kahn SE; RISE Consortium. OGTT Glucose Response Curves, Insulin Sensitivity, and beta-Cell Function in RISE: Comparison Between Youth and Adults at Randomization and in Response to Interventions to Preserve beta-Cell Function. Diabetes Care. 2021 Mar;44(3):817-825. doi: 10.2337/dc20-2134. Epub 2021 Jan 12. |
| 31301210 | Derived | RISE Consortium. Obesity and insulin sensitivity effects on cardiovascular risk factors: Comparisons of obese dysglycemic youth and adults. Pediatr Diabetes. 2019 Nov;20(7):849-860. doi: 10.1111/pedi.12883. Epub 2019 Jul 29. |
| 29941498 | Derived | RISE Consortium. Metabolic Contrasts Between Youth and Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes: II. Observations Using the Oral Glucose Tolerance Test. Diabetes Care. 2018 Aug;41(8):1707-1716. doi: 10.2337/dc18-0243. Epub 2018 Jun 25. |
| 28493515 | Derived | Hannon TS, Kahn SE, Utzschneider KM, Buchanan TA, Nadeau KJ, Zeitler PS, Ehrmann DA, Arslanian SA, Caprio S, Edelstein SL, Savage PJ, Mather KJ; RISE Consortium. Review of methods for measuring beta-cell function: Design considerations from the Restoring Insulin Secretion (RISE) Consortium. Diabetes Obes Metab. 2018 Jan;20(1):14-24. doi: 10.1111/dom.13005. Epub 2017 Jun 22. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hyperglycemic clamp | data are reported as gemetric mean and 95% confidence interval | Geometric Mean | Inter-Quartile Range | nmol/l adjusted for insulin sensitivity |
|
| Oral Glucose Tolerance Test | Mean | Standard Deviation | mmol/l |
|
| Body weight | Mean | Standard Deviation | kilograms |
|
| Body Mass Index | Mean | Standard Deviation | kilograms per meters squared |
|
| Hemoglobin A1C | values are given as standard error and not standard deviation | Mean | Standard Deviation | percent of hemoglobin |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Other Pre-specified | Glycemia | fasting and 2-hour OGTT glucose levels | participants completing 24 months of interventions | Posted | Mean | Standard Error | mmol/l | 24 months |
|
|
|
| Other Pre-specified | Glycemia | HbA1C | participants completing 24 months of interventions | Posted | Mean | Standard Error | percent of hemoglobin | 24 months |
|
|
|
| 39 |
| 2 |
| 39 |
| 18 |
| 39 |
| EG001 | Gastric Banding | subjects receiving LAP-BAND gastric banding: LAP-BAND | 0 | 38 | 4 | 38 | 3 | 38 |
|
| breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| acalcuous cholecystitis | Gastrointestinal disorders | Systematic Assessment | Requering gall bladder removal |
|
| Ankle fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | requiring fixation, resutling from traffic accident |
|
| Gastric sleeve surgery | Gastrointestinal disorders | Systematic Assessment | elective |
|
| dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| stomach pain or discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| dairrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Lack of energy | General disorders | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |