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OpenTrials
Completed

NCT Number: NCT04313920

Study of a Carbohydrate Drink in Adults

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Awareness, Inc., Jupiter, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional Supplement

Other

50 g Carbohydrate

Primary outcomes

  1. Plasma Glucose Concentration

    Time frame: Baseline 0 to 240 Minutes

    Area under the curve

Secondary outcomes

  1. Serum Insulin Concentration

    Time frame: Baseline 0 to 240 Minutes

    Area under the curve

  2. Nutritional Product Assessment

    Time frame: Immediately following product consumption

    Subject completed questionnaire with 2 product liking questions using 7-9 point Likert scale

  3. Subjective Appetitive Ratings

    Time frame: Baseline 0 to 240 Minutes

    Subject completed 4 visual analog scale statements scaled from Not at All to Extremely

  4. Gastric Emptying

    Time frame: Baseline 0 to 180 Minutes

    Rate of gastric emptying

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 18, 2020
Registry last updated
Oct 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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