Study of a Carbohydrate Drink in Adults

Study Overview
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Brief Summary
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The objective of this study is to determine the postprandial glycemic response and rates of gastric emptying in healthy subjects and those with pre-diabetes and type 2 diabetes following oral ingestion of carbohydrate.

Official Title
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Postprandial Gastric Emptying and Glycemic Response to a Pre-Operative Carbohydrate Drink in Adults With Pre-diabetes and Type II Diabetes Mellitus

Conditions
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Glycemic Response

Intervention / Treatment
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* Other: Nutritional Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has voluntarily signed and dated an informed consent form and provided Health Insurance Portability and Accountability Act (HIPAA) authorization Subject is healthy or has pre-diabetes or type 2 diabetes Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum Subject's BMI is > 18.5 kg/m2 and ≤ 40.0 kg/m2 If subject is on a chronic medication, the dosage has been constant Subject states willingness to follow protocol Exclusion Criteria: Subject uses exogenous insulin or Glucagon-like peptide-1 (GLP-1) receptor agonists for glucose control Subject has type 1 diabetes Subject has a history of diabetic ketoacidosis Subject has current infection; has had in-patient surgery, or corticosteroid treatment or antibiotics Subject has an active malignancy Subject has had a significant cardiovascular event ≤ six months or history of congestive heart failure Subject has end-stage organ failure or is status post organ transplant. Subject has a history of renal disease Subject has current hepatic disease Subject has a history of severe gastroparesis Subject has a chronic, contagious, infectious disease Subject has taken/is currently taking any herbals, dietary supplements, or medications that could profoundly affect blood glucose Subject has clotting or bleeding disorders Subject is known to be allergic or intolerant to any ingredient found in the study products Subject is a participant in another study that has not been approved as a concomitant study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional Supplement<br>Ready to drink liquid | Other: Nutritional Supplement<br>* 50 g Carbohydrate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Glucose Concentration | Area under the curve | Baseline 0 to 240 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Insulin Concentration | Area under the curve | Baseline 0 to 240 Minutes | 
| Nutritional Product Assessment | Subject completed questionnaire with 2 product liking questions using 7-9 point Likert scale | Immediately following product consumption | 
| Subjective Appetitive Ratings | Subject completed 4 visual analog scale statements scaled from Not at All to Extremely | Baseline 0 to 240 Minutes | 
| Gastric Emptying | Rate of gastric emptying | Baseline 0 to 180 Minutes |