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| Name | Class |
|---|---|
| Kilo Diabetes & Vascular Research Foundation | UNKNOWN |
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The purpose of this study is to compare the metabolic responses to low-carbohydrate and standard-carbohydrate meals in African Americans and non-Hispanic White adults with obesity and the effect of weight loss induced by low-calorie diet (LCD) or Roux-en-Y gastric bypass (RYGB) on the metabolic responses to low-carbohydrate and standard meals. Participants will consume: 1) a standard-carbohydrate meal (~49 g glucose) and 2) a low-carbohydrate (~3.4 g glucose) meal on separate study visits performed in a randomized order. We will evaluate the meals' effect before and after ~16-18% weight loss on postprandial i) insulin kinetics, ii) glucose kinetics iii) β-cell function; iv) plasma triglyceride and non-esterified fatty acid concentrations; v) plasma hormone concentrations; vi) plasma cytokine concentrations; vi) plasma metabolomics; and vii) adipose tissue transcriptomics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RYGB group | Experimental | Subjects in this group are scheduled to undergo Roux-en-Y gastric bypass surgery and will be assessed after ~16-18% weight-loss |
|
| LCD Group | Active Comparator | Subjects in this group will participate in a low-calorie diet intervention to achieve ~16-18% weight loss. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roux-en-Y gastric bypass surgery | Procedure | Roux-en-Y gastric bypass surgery will be performed with post-weight loss testing performed after ~16-18% weight loss is achieved. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial plasma insulin kinetics | Plasma insulin kinetics will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal. | Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity) |
| Postprandial plasma insulin kinetics | Plasma insulin kinetics will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal. | After 16-18% weight loss induced by LCD or RYGB (~4-6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial glucose kinetics | Plasma glucose kinetics will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal. | Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity) |
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Inclusion Criteria:
Surgery Group (RYGB):
LCD group:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Klein, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Henk | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38093006 | Derived | Li E, Wang L, Wang D, Chi J, Lin Z, Smith GI, Klein S, Cohen P, Rosen ED. Control of lipolysis by a population of oxytocinergic sympathetic neurons. Nature. 2024 Jan;625(7993):175-180. doi: 10.1038/s41586-023-06830-x. Epub 2023 Dec 13. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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| Low-calorie diet | Behavioral | Subjects will meet with a dietitian and/or behaviorist over 4-6 months to lose ~16-18% of their body weight. |
|
| Postprandial glucose kinetics |
Plasma glucose kinetics will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal. |
| After 16-18% weight loss induced by LCD or RYGB (~4-6 months) |
| β-cell function | β-cell function will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal. | Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity) |
| β-cell function | β-cell function will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal. | After 16-18% weight loss induced by LCD or RYGB (~4-6 months) |
| Postprandial triglyceride concentrations | Plasma triglyceride concentrations will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal. | Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity) |
| Postprandial triglyceride concentrations | Plasma triglyceride concentrations will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal. | After 16-18% weight loss induced by LCD or RYGB (~4-6 months) |
| Postprandial non-esterified fatty acid concentrations | Plasma non-esterified fatty acid concentrations will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal. | Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity) |
| Postprandial non-esterified fatty acid concentrations | Plasma non-esterified fatty acid concentrations will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal. | After 16-18% weight loss induced by LCD or RYGB (~4-6 months) |
| Postprandial hormone concentrations | Plasma hormone concentrations will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal. | Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity) |
| Postprandial hormone concentrations | Plasma hormone concentrations will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal. | After 16-18% weight loss induced by LCD or RYGB (~4-6 months) |
| Postprandial cytokine concentrations | Plasma cytokine concentrations will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal. | Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity) |
| Postprandial cytokine concentrations | Plasma cytokine concentrations will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal. | After 16-18% weight loss induced by LCD or RYGB (~4-6 months) |
| Postprandial lipids | Plasma lipids will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal by using mass spectrometry. | Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity) |
| Postprandial lipids | Plasma lipids will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal by using mass spectrometry. | After 16-18% weight loss induced by LCD or RYGB (~4-6 months) |
| Postprandial metabolites | Plasma metabolites will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal by using mass spectrometry. | Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity) |
| Postprandial metabolites | Plasma metabolites will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal by using mass spectrometry. | After 16-18% weight loss induced by LCD or RYGB (~4-6 months) |
| Transcriptome in adipose tissue | The transcriptome (all RNA that are responsible for making proteins from DNA templates) will be evaluated by using RNA sequencing techniques in adipose tissue samples collected before and ~3h after consuming a standard-carbohydrate or a low-carbohydrate meal. | Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity) |
| Transcriptome in adipose tissue | The transcriptome (all RNA that are responsible for making proteins from DNA templates) will be evaluated by using RNA sequencing techniques in adipose tissue samples collected before and ~3h after consuming a standard-carbohydrate or a low-carbohydrate meal. | After 16-18% weight loss induced by LCD or RYGB (~4-6 months) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |