A Study of the Effects of a Nocturnal Rise in Cortisol on Glucose Production in Type 2 Diabetes
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-008977
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Kelly Dunagan, R.N. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available