Status:
COMPLETED
Study of a Carbohydrate Drink in Adults
Lead Sponsor:
Abbott Nutrition
Conditions:
Glycemic Response
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 ingestio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2020
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT04313920
Start Date
April 7 2020
End Date
August 26 2020
Last Update
October 6 2020
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Health Awareness, Inc.
Jupiter, Florida, United States, 33458
2
Biofortis
Addison, Illinois, United States, 60101
3
Great Lakes Clinical Trials
Chicago, Illinois, United States, 60640