Study of variations in the gut microbiome using 16S rRNA gene sequencing and microbial metabolites in adolescents with Type 2 diabetes when compared to age-matched obese controls.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Type 2 Diabetes Mellitus
  • Age: Between 12 - 23 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Adolescents with Type 2 Diabetes mellitus between the ages of 12- 23 years, who have had T2DM for at least 6-month duration, and who have had a HbA1c > 8% in the preceding 3 months prior to enrollment into the study.
    2. Confirmed T2DM as defined by American Diabetes Association i.e. FPG > 126 mg/dL or blood sugar > 200 mg/dl on a 2 hr, 75 g OGTT or random blood sugar >200 mg/dl. Pubertal, Tanner stage >1.
    3. Subjects must be willing to comply with study protocol requirements.
    4. Females must have a negative pregnancy test within 72 hours prior to the start of the study.
    5. The patient must be on insulin to qualify for the study. The adolescents could be on oral hypoglycemic agent in addition to insulin to be included in the study.

You may not be eligible for this study if the following are true:

    1. Chart review of adolescents with T2DM will be done to confirm absence of glutamic acid decarboxylase, islet cell or insulin autoantibodies or secondary causes of diabetes.
    2. Other significant major organ system illness.
    3. Females who are pregnant.
    4. Significant psychiatric illness: schizophrenia, bipolar disorder, active substance abuse and uncontrolled major depression.
    5. All adolescents who have signs of renal insufficiency (creatinine clearance based on Schwartz equation >0.55 for females and males 0.7 ages 13-18 years) (13). Serum creatinine will be available on the metabolic profile. Subjects with elevated CrCl will be excluded from the study.
    6. Any subject not deemed an appropriate candidate by the principal investigator for study selection.

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