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Search / Trial NCT00950677

The Effect of Byetta and Symlin on Post-meal Meal Blood Sugar Levels in Children With Type 2 Diabetes

Launched by BAYLOR COLLEGE OF MEDICINE · Jul 31, 2009

Trial Information

Current as of May 17, 2025

Completed

Keywords

Diabetes Pramlintide Symlin Exenatide Byetta Glucagon Gastric Emptying

ClinConnect Summary

A large study in people with type 2 diabetes (T2DM) showed that lowering blood sugars stopped or delayed the occurrence of health problems. As a result of the study, treatment should try to control blood sugars as near to normal as safely possible.

In people without diabetes, the "after meal" blood sugar level is very carefully controlled by several hormones. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in keeping this careful balance. Also, we now know of 2 new substances made by the body called amylin and GLP-1 that also hel...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Children with Type 2 Diabetes,
  • Between the ages of 12-21 years,
  • Tanner stage 4-5 for pubertal development,
  • Menstruating females must have a negative urine pregnancy test for inclusion,
  • Must have T2DM for at least 6 months,
  • History of negative anti-glutamic acid decarboxylase (GAD) -65 and anti-islet cell antibodies,
  • HbA1c \< 8.5% and on a stable dose of an oral hypoglycemic agent (with or without insulin) over the last 2 months, or well controlled on diet.
  • Exclusion Criteria:
  • A history of a chronic disease other than diabetes (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, dyslipidemia, cholelithiasis etc),
  • BMI\> 40 kg/m2,
  • Weight of \< 60 kg,
  • Female with menstrual irregularities,
  • Allergy to local anesthetics (ELAMAX Cream, Ethyl Chloride),
  • Evidence or history of chemical abuse,
  • Anemia (age specific normal range for hemoglobin will be used),
  • Elevated liver enzymes (defined as more than 3 times the upper limit of the normal range for age),
  • Elevated BUN or creatinine (defined as more than 3 times the upper limit of the normal range for age),
  • Use of medications that may increase the blood sugars and admission to the hospital for diabetes related problems over the last 6 months.

About Baylor College Of Medicine

Baylor College of Medicine is a leading academic institution dedicated to advancing health through innovative research, education, and clinical care. Located in Houston, Texas, it is renowned for its commitment to excellence in medical education and translational research, fostering collaborations that bridge laboratory discoveries with clinical application. As a clinical trial sponsor, Baylor College of Medicine leverages its robust infrastructure, interdisciplinary expertise, and access to diverse patient populations to conduct cutting-edge clinical studies aimed at improving patient outcomes and enhancing therapeutic approaches across a wide range of medical conditions.

Locations

Houston, Texas, United States

Patients applied

0 patients applied

Trial Officials

LUISA M RODRIGUEZ, MD

Principal Investigator

Baylor College of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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