Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DK091748 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if interruption in gastric-adipose tissue axis signaling contributes to early improvements in oxidative stress, insulin sensitivity, and inflammation, and to determine if interruption of the stomach in RYGB results in reduction of plasma acylated ghrelin (AG) and in an altered acylated ghrelin:unacylated ghrelin (AG:UAG) ratio which may contribute to decreased oxidative stress and improved insulin sensitivity.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RYGB | Experimental | Roux-en-Y gastric bypass surgery (RYGB) subjects to undergo hyperinsulinemic-euglycemic clamp with human ghrelin infusion pre-operatively and post-operatively. |
|
| VSG | Experimental | Vertical sleeve gastrectomy (VSG) subjects to undergo hyperinsulinemic-euglycemic clamp pre-operatively and post-operatively. |
|
| Low Calorie Diet | Experimental | Subjects will receive very low calorie diet prescribed for RYGB patients and undergo hyperinsulinemic-euglycemic before and after diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human ghrelin | Drug | 0.5-1 pmol/kg.min of human ghrelin administered by IV two times |
| |
| Measure | Description | Time Frame |
|---|---|---|
| change in glucose disposal rate | Glucose disposal rate is a sensitive laboratory procedure for determining how your body uses sugar (called insulin sensitivity). | baseline and 1 week |
Not provided
Not provided
PROTOCOL I
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Naji Abumrad, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 34232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35724307 | Derived | Flynn CR, Tamboli RA, Antoun J, Sidani RM, Williams B, Spann MD, English WJ, Welch EB, Sundaresan S, Abumrad NN. Caloric Restriction and Weight Loss Are Primary Factors in the Early Tissue-Specific Metabolic Changes After Bariatric Surgery. Diabetes Care. 2022 Aug 1;45(8):1914-1916. doi: 10.2337/dc22-0069. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D054439 | Ghrelin |
| D015309 | Glucose Clamp Technique |
| ID | Term |
|---|---|
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| very low calorie diet |
| Other |
standard very low calorie diet that is prescribed for all RYGB patients after their operation |
|
| Hyperinsulinemic/Euglycemic Clamp | Procedure | Insulin and glucose infusions to measure glucose kinetics. |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |