Novel Type 2 Diabetes Mellitus Preventive Therapies

Because of recruitment difficulties the design was modified several times until April 2013 when we were able to increase recruitment. The following changes were made from initial to final study design:

• Study moved from Clinical and Translational Science Institute (CTSI) to clinical setting (Nutrition and Fitness for Life Clinic)
• Ages eligible expanded from 12-19 years old to 12-19.9 years old
• Ethnicity/Race expanded from Hispanic only to include all races/ethnicities
• Patients without a past family history of T2DM were made eligible
• Study period was shortened from 6 months to 12-14 weeks
• Number of required visits were reduced from 5 visits to 3 visits (all of which took place during regularly scheduled clinic appointments)
• Open labeled but still randomized
• Those in the Glutamine arm were provided lifestyles change intervention
• Glycosylated hemoglobin (A1C) used instead of fasting Homeostatic Model Assessment-Insulin Resistance (HOMA-IR)
• Non-fasting blood draw rather than a fasting blood draw was instituted

Inclusion criteria

• BMI (k/m2) >= 95th percentile;
• Weight 150 - 400 pounds;
• Language: English or Spanish (The PI speaks both English and Spanish fluently).

Exclusion criteria

• History of T2DM;
• Prior or current drug treatmeant that would effect diabetes risk
• Use of prescription strength glucocorticoids within three months before screening,
• History of syndrome or medical disorder associated with significant obesity;
• Serum creatinine >1.2 mg/dL;
• Alanine transaminase (ALT) or Aspartate aminotransferase (AST) >90 international units (IU)/L (= 3 X normal limits);
• Total bilirubin >2.5 time the upper limit of normal;
• History of moderate to extreme physical activity, past or current pregnancy;

9 .Use of illegal/illicit drugs;

• Unable to comply with the protocol;

• Any other serious disease determined by the clinician as potential study risk for the patient.

• Have kidney or liver disorders, or conditions resulting in ammonia accumulation

• Take Lactulose

• Are allergic to monosodium glutamate (MSG), glutamine, or Crystal Light

• Have manic episodes (mental illness)

• Take medications to prevent seizures

• Take any glutamine, supplement with glutamine, hypoglycemiants, anticonvulsivant, ADHD medications, antilipidemiants, or thyroid hormone

• Participation in a weight loss program or use of weight loss medications within six months of screening that has resulted in 5% or more weight loss