Treatment of the very insulin resistant obese patient with type 2 diabetes

Not Applicable

• Conditions: Nutritional, Metabolic, Endocrine; Diabetes type 2

• Registration Number: PACTR201308000617367
• Lead Sponsor: Dr LA Distiller

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-14
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Male or female subjects aged 18-75 years;
A history of type 2 diabetes for at least 1 year defined according to the ADA criteria;
Total daily insulin requirements of >200 U daily for at least 3 months;
HbA1c >7.5 %;
Body Mass Index (BMI) >30 kg/m2;
Able and willing to understand the protocol and sign informed consent;
Able and willing to perform SHGM;
Women of childbearing potential must be willing to use adequate contraception for the duration of the study.

Exclusion Criteria

Pregnancy or planned pregnancy in women of childbearing potential;
Use of any of the excluded medication as outlined above;
Any known or suspected underlying endocrinopathy that may be aggravating of causing the insulin resistant state (e.g. Cushings syndrome, acromegaly, glucagonoma etc);
Any diagnosed chronic inflammatory or systemic autoimmune disorder which may potentiate the insulin resistant state;
Any clinically significant disease or disorder, except for those conditions associated with type 2 diabetes, which in the investigators opinion could interfere with the results of the study;
Any patients who, in the opinion of the investigator, are unable to conceptualise and understand the differences between and dosages of U-500 and U-100 insulin;
Documented significant CVD (unstable angina, heart failure, coronary artery stenting of bypass surgery in past 6 months);
The presence of an active carcinoma or other chronic illness, which may interfere with glycaemic control or potential longevity;
Severe renal dysfunction (eGFR <30 ml/min);
Unable or unwilling to perform SHGM;
History of gastroparesis or other significant upper gastrointestinal pathology.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in A1C from baseline (the start of the study) and at 12 and 24 weeks and between groups; Differences in Fasting plasma glucose from baseline (the start of the study) and at 12 and 24 weeks and between groups; Differences at 12 and 24 weeks in 7-point glucose profiles from baseline (the start of the study) and at 12 and 24 weeks and between groups.;A1C; Fasting plasma glucose; 7-point glucose profiles

Secondary Outcome Measures

Name	Time	Method
Body weight Insulin dose Serum lipid concentrations Hepatic enzymes, SFPT, SGOT, Gamma-GT