Glucose Tolerance in Healthy Overweight Adults

Abbott

Status and phase

Completed

Phase 2

Conditions

Overweight

Treatments

Other: Amino Acid Drink Mixture

Other: Glucose drink

Study type

Interventional

Funder types

Industry

Identifiers

NCT00974831

BK51

Details and patient eligibility

About

The primary objective is to compare the postprandial glycemic response of healthy overweight adults after consuming an amino acid drink mix versus a control drink.

Enrollment

24 patients

Sex

All

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Fasting blood glucose level of ≥ 70mg/dL and ≤ 125 mg/dL.
Subject states that he/she does not have type 1 or 2 diabetes.
Subject is overweight as defined as waist circumference ≥ 101 cm (40 inches) male; ≥ 88 cm (35 inches) female.
Subject's BMI is ≥ 25 kg/m2.
Subject's blood pressure is < 140 mm Hg systolic and < 90 mm Hg diastolic.
Subject is between 20 and 45 years of age, inclusive.
Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
If female is of childbearing potential, is practicing birth control
If subject is on a chronic medication such as a thyroid medication or hormone therapy, has been on constant dosage for at least two months prior to screening visit.

Exclusion criteria

Subject is eating a low carbohydrate diet such as Atkins, Zone, or South Beach diet plan.
Subject states that he/she has current infection, has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
Subject states that he/she has an active malignancy.
Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
Subject states that he/she has end-stage organ failure or is status post organ transplant.
Subject states that he/she has a history of renal disease.
Subject states that he/she has current hepatic disease.
Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
Subject has taken/is currently taking any herbals, dietary supplements, or medications during the past four weeks prior to screening visit that could profoundly affect blood glucose.
Subject has taken/is currently taking any herbals, dietary supplements, or medications during the past four weeks prior to screening visit to control hypertension or cholesterol.
Subject states that he/she has clotting or bleeding disorders.