Study of a Carbohydrate Drink in Adults

Glycemic Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04313920
• Other study ID #: BL48
• Status: Completed
• Phase: N/A
• Start date: April 7, 2020
• Est. completion date: August 26, 2020

Study information

• Verified date: October 2020
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: August 26, 2020
• Est. primary completion date: August 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Glycemic Response

Intervention

Other:
• Nutritional Supplement
50 g Carbohydrate

Locations

Country	Name	City	State
United States	Biofortis	Addison	Illinois
United States	Great Lakes Clinical Trials	Chicago	Illinois
United States	Health Awareness, Inc.	Jupiter	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

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