Study of a Carbohydrate Drink in Adults

Abbott

Status

Completed

Conditions

Glycemic Response

Treatments

Other: Nutritional Supplement

Study type

Interventional

Funder types

Industry

Identifiers

NCT04313920

BL48

Details and patient eligibility

About

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.

Enrollment

97 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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