Clinical trial NCT04313920: Study of a Carbohydrate Drink in Adults
Official title: Postprandial Gastric Emptying and Glycemic Response to a Pre-Operative Carbohydrate Drink in Adults With Pre-diabetes and Type II Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Response
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2020-03-18
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 ingestion of carbohydrate.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma Glucose Concentration
timeFrame: Baseline 0 to 240 Minutes
Secondary outcomes:
measure: Serum Insulin Concentration
timeFrame: Baseline 0 to 240 Minutes
measure: Nutritional Product Assessment
timeFrame: Immediately following product consumption
measure: Subjective Appetitive Ratings
timeFrame: Baseline 0 to 240 Minutes
measure: Gastric Emptying
timeFrame: Baseline 0 to 180 Minutes
Other outcomes:
Locations:
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Addison
country: United States
facility: Biofortis
state: Illinois
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
Study officials:
affiliation: Abbott Nutrition
name: Bridget Cassady, PhD, RDN, LD
role: STUDY_CHAIR
References: