The Role of Amylin and Glucagon in T1DM

NCT00206258 | Completed Phase 3

• 1 other identifier: H-11741
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if giving pramlintide and insulin before a meal would lower high blood sugar and if a glucagon (a naturally made hormone in the body but reduced in diabetes and its role is in prevention of low blood sugar) shot given in the late "after meal" time would prevent low blood sugar. The studies outlined in this proposal might help in developing new treatment options to target "after meal" high blood sugar and before meal low blood sugar in children. This would possibly help improve overall blood sugar control and prevent the long-term complications of diabetes.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; hypoglycemia; hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Area under the curve for glucose

Secondary Outcomes (1)

• Glucagon and gastric emptying

Interventions

Pramlintide and glucagon DRUG

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age \>12 years \< 19 years
• Have diabetes for at least 2 years and in good control (HbA1C \< 8%).
• Be on continuous subcutaneous insulin infusion using an insulin pump.
• Subjects must be otherwise healthy except for their T1DM and treated for hypothyroidism.
• Menstruating women must have negative pregnancy test.
• Hemoglobin equal to or \> than 12 g/dL before each study.
• Weight more than 44 kg.

You may not qualify if:

• Age \>18 or \< 12 y at the time of study
• Any chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc that directly, or as a result of treatment, directly or indirectly affect glucose homeostasis
• Hemoglobin less than 12 g/dl (If before any of the studies the hemoglobin is lower than 12 g/dl, subjects will be excluded from further studies)
• Lack of a supportive family environment
• Positive pregnancy test in menstruating young women
• Evidence or history of chemical abuse
• Hgb A1c \>8.0 % in a diabetic subject
• BMI \> 90 % tile for age or \< 10 % tile for age
• Allergy to local anesthetics (ELAMAX Cream)
• Weight less than 44 kg
• Children of staff members

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Heptulla RA, Rodriguez LM, Bomgaars L, Haymond MW. The role of amylin and glucagon in the dampening of glycemic excursions in children with type 1 diabetes. Diabetes. 2005 Apr;54(4):1100-7. doi: 10.2337/diabetes.54.4.1100.

  PMID: 15793249 RESULT

Related Links

• Learn about the physiology of amylin

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Hyperglycemia

Interventions

pramlintide; Glucagon

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Rubina Heptulla, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 21, 2005
• Study Start: July 1, 2002
• Study Completion: August 1, 2005
• Last Updated: July 14, 2016

Record last verified: 2016-07

Locations

US (1)