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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK089557 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Weight loss is effective in reducing many complications of obesity, with the majority of patients who undergo bariatric surgery having substantial improvements in their weight-related illnesses. The investigators propose a pilot study in 45 subjects with mild to moderate obesity to compare how losing 10% of initial body weight via one of three common weight loss strategies (medical weight loss with a low calorie diet, Roux-en-Y gastric bypass surgery, and adjustable gastric banding) affects diabetes. While the investigators do not expect this pilot study to provide definitive answers, it will provide valuable information to design a larger trial which will help guide therapy for people with mild-moderate obesity and substantial comorbidities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric Banding | Active Comparator | Laparoscopic Adjustable Gastric Banding |
|
| Medical Weight Loss | Active Comparator | Medical Weight Loss using a comprehensive lifestyle intervention consisting of diet (meal replacements), physical activity and behavioral techniques |
|
| Gastric Bypass | Active Comparator | Roux-en-Y Gastric Bypass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric Banding | Procedure | Laparoscopic Adjustable Gastric Banding using the LapBand |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c from baseline to final data collection | Participants will be followed until they reach 10% weight loss, anticipated average time 6 months, or up to 9 months. | Average time 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin secretion | Participants will be followed until they reach 10% weight loss, and anticipated average of 6 months, or up to 9 months. | Average time 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeanne M. Clark, MD, MPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30997619 | Result | Varma S, Lee CJ, Brown TT, Maruthur NM, Schweitzer M, Magnuson T, Kamel I, Clark JM. Comparative Effects of Medical Versus Surgical Weight Loss on Body Composition: a Pilot Randomized Trial. Obes Surg. 2019 Aug;29(8):2503-2510. doi: 10.1007/s11695-019-03879-4. | |
| 31256356 | Result | Lee CJ, Florea L, Sears CL, Maruthur N, Potter JJ, Schweitzer M, Magnuson T, Clark JM. Changes in Gut Microbiome after Bariatric Surgery Versus Medical Weight Loss in a Pilot Randomized Trial. Obes Surg. 2019 Oct;29(10):3239-3245. doi: 10.1007/s11695-019-03976-4. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
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| Medical Weight Loss |
| Behavioral |
Weight loss intervention using diet (meal replacments), physical activity and behavioral techniques administered with weekly one-on-one counselling by dieticians |
|
|
| Gastric Bypass | Procedure | Laparoscopic Roux-en-Y Gastric Bypass |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005763 |
| Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |