Insulin Clamp Ancillary Study for Assessment of Insulin Resistance

Type 1 Diabetes Clinical Trial

Official title:

Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (T1D)--Insulin Clamp Ancillary Study for Assessment of Insulin Resistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02045290
• Other study ID #: T1DX Insulin Clamp Ancillary
• Status: Completed
• Phase: Phase 3
• First received: January 15, 2014
• Last updated: March 10, 2017
• Start date: January 2014
• Est. completion date: February 15, 2016

Study information

• Verified date: March 2017
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Insulin Clamp Ancillary study for Assessment of Insulin Resistance will be conducted as a sub-study to the main protocol, Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (NCT01881828). The purpose of this ancillary study is to assess if metformin will improve tissue-specific insulin resistance (IR) in type 1 diabetes using a hyperinsulinemic euglycemic clamp; a 3-month randomized trial comparing metformin versus placebo in 12 to <20 year olds with BMI >85th percentile ( total daily insulin dose >0.7 units/kg, and HbA1c 7.0%-9.9%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 15, 2016
• Est. primary completion date: February 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

Inclusion Criteria:

1. Meets eligibility criteria of the main study, Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (NCT01881828).

Exclusion Criteria:

1. Low hemoglobin or hematocrit as defined by each local institution's rules for insulin clamps or if no institutional requirements a Hematocrit <30% or hemoglobin <10 gm/dL

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Insulin Resistance
• Type 1 Diabetes

Intervention

Drug:
• Metformin
The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in the morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
• Placebo

Locations

Country	Name	City	State
United States	Jaeb Center for Health Research	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (45)

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insulin resistance (IR) from baseline to 13 weeks	Hyperinsulinemic euglycemic clamp to assess metformin's impact on muscle IR via glucose infusion rate (GIR).	0-13 weeks
Secondary	Change in Hepatic IR from baseline to 13 weeks	Graded hyperinsulinemic euglycemic clamp with glucose and glycerol isotopes to assess metformin's impact on: • Hepatic IR	0-13 weeks
Secondary	Change in Adipose IR from baseline to 13 weeks	Graded hyperinsulinemic euglycemic clamp with glucose and glycerol isotopes to assess metformin's impact on: • Adipose IR	0-13 weeks