Clinical trial NCT00974831: Glucose Tolerance in Healthy Overweight Adults
Official title: Glucose Tolerance in Healthy Overweight Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2009-09-10
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Fasting blood glucose level of ≥ 70mg/dL and ≤ 125 mg/dL.
2. Subject states that he/she does not have type 1 or 2 diabetes.
3. Subject is overweight as defined as waist circumference ≥ 101 cm (40 inches) male; ≥ 88 cm (35 inches) female.
4. Subject's BMI is ≥ 25 kg/m2.
5. Subject's blood pressure is \< 140 mm Hg systolic and \< 90 mm Hg diastolic.
6. Subject is between 20 and 45 years of age, inclusive.
7. Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
8. If female is of childbearing potential, is practicing birth control
9. 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:

1. Subject is eating a low carbohydrate diet such as Atkins, Zone, or South Beach diet plan.
2. 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.
3. Subject states that he/she has an active malignancy.
4. Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
5. Subject states that he/she has end-stage organ failure or is status post organ transplant.
6. Subject states that he/she has a history of renal disease.
7. Subject states that he/she has current hepatic disease.
8. Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
9. 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.
10. 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.
11. Subject states that he/she has clotting or bleeding disorders.

Primary outcomes:
measure: The primary variable is the positive area under the curve from 0 to 180 minutes for plasma glucose.
timeFrame: 0-180 minutes
Secondary outcomes:
measure: Plasma glucose, insulin, C-peptide, free fatty acids, and glucagon concentration data over time
timeFrame: 0-180 minutes
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas
state: Texas
Study officials:
affiliation: Abbott Nutrition
name: Jeffrey Nelson, PhD
role: STUDY_CHAIR
References: