Glucocorticoid Effects in Patients With DM Type 2

16-035

Participants will receive prednisone 40 mg for 3 days. 75 g oral glucose tolerance test (OGTT), insulin and C-peptide will be measured on day 1 (before prednisone) and day 3 (after prednisone). Also capillary glucose values will be obtained during and after the period of prednisone intake.

2016-06-03

2017-04-01

2017-07-01

Completed

Early phase I

10

Experimental Group Inclusion Criteria: 1. Males or non-pregnant females between the ages of 18-50 years being followed in the Diabetes Center. 2. Type 2 Diabetes for ≤ 1 year and only on metformin 3. BMI 24.0-35.0 kg/ m2 4. HBA1c ≤ 9.0% Exclusion Criteria: 1. Patients on any other antidiabetes medication. 2. Patients with impaired renal function (estimated Glomerular Filtration Rate (GFR) less than 60 ml/min based on results from Cerner). 3. Patient who have received glucocorticoid therapy within six months of study. 4. Patients who do shift work. 5. Blood glucose level ≥ 250 mg/dl on finger-stick at clinic visit. 6. Signs or symptoms of infection. Control Group Inclusion Criteria: 1. Males or non-pregnant females between the ages of 18-50 years in good physical health as determined by medical history, physical examination, and screening blood tests 2. Normoglycemia defined by fasting plasma glucose \< 5.6 mmol/L (or 100 mg/dL) and 2h glucose \<7.8 mmol/L (or 140 mg/dL) after a 75 g OGTT 3. BMI: 22.0 - 28.0 kg/m2 Exclusion Criteria: 1. Presence of any disease or use of any medication 2. Patients with a first-degree relative with Type 2 Diabetes 3. Patients who smoke 4. Patients with history of steroid use in previous 6 months. 5. Patients who do shift work 6. Signs or symptoms of infection. 7. Patients with recent changes in weight or physical activity

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Two groups. Condition group and Control group, both receiving the investigated medication using the same protocol', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}

2023-09-26