A Study of the Effects of a Nocturnal Rise in Cortisol on Glucose Production in Type 2 Diabetes

Overview

Sponsor Protocol Number: 14-008977

About this study

The purpose of this study is to assess the effects of a nighttime rise in cortisol on the body's glucose production in type 2 diabetes.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria

  • 30-75 years of age
  • A body mass index (BMI) of 27-40 kg/m2
  • Groups of healthy controls and type 2 diadetic patients will be matched for age, sex and BMI
  • ADA criteria for fasting glucose will be applied
  • Type 2 diabetes patients can be on lifestyle treatment, with or without monotherapy, with either metformin or sulfonylurea (SU) or combination therapy with insulin, with HbA1c <10% 
  • Subjects on thiazolidinediones may be included if they agree to stop these medications for at least 3-4 weeks before study visits
  • All women of childbearing potential will have a negative pregnancy test within 24 hours of the study visit
  • Subjects meeting enrollment criteria on metformin and/or sulfonylurea will be asked to withdraw these drugs for 2 weeks prior to study visit and to monitor their fingerstick glucoses regularly during this period
  • Subjects on long acting insulin will stop their insulin 24 hours before study admit day and continue short acting insulin as needed

Exclusion Criteria

  • A history of sleep disorders, to minimize confounding the outcome variables
  • Type 2 diabetics with microvascular or macrovascular complications (apart from mild background retinopathy)
  • Sleep related disorders

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20200417

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