Conditioning of insulin responses: a high rist- high gain intervention for diabetes type-2
- Conditions
- diabetes type-210012653
- Registration Number
- NL-OMON49422
- Lead Sponsor
- niversiteit Leiden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 64
For patients:
- Diagnosis of diabetes mellitus type 2
- Taking metformin or participating in a life style intervention (e.g., diet)
- Use of insulin or, insulin stimulating medications ;
- Use of medication that influences glucose metabolism, for example,
corticosteroid medication, chemotherapy, beta-blockers;
- Diagnosis of an acute not-infectious disease (degenerative diseases,
malignant neoplasms such as cancer, diabetes type-1, auto-immune diseases);
- Diagnosis of an acute infectious diseases (such as meningitis, hepatitis B,
bacterial pneumonia);
- Current diagnosis of a mental disorder;
- Chronic and/or acute rhinitis, anatomic deviations of the nose;
- Substance abuse (e.g., drugs or alcohol);
- Pregnancy or an intention to get pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters are blood insulin and glucose levels during the evocation<br /><br>day in the experimental patients group versus the control patients group.<br /><br>Insulin and glucose will be measured 8 times: at baseline, after each of the 6<br /><br>applications of nasal spray and 15 minutes after the last spray administration. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondly, we investigate the effects of conditioning with insulin on C-peptide,<br /><br>hunger, approach-avoidance tendencies, food intake and cognitive functioning<br /><br>measured with a memory task. Finally, a comparison between patients and healthy<br /><br>participants will be made on the study outcomes.</p><br>