Diabetes type-2
Conditions
Interventions
In the conditioned groups, participants will receive 6 intranasal applications of 20 IU insulin during the acquisition day and 6 applications of a placebo nasal spray during the evocation day. In the
Sponsors
Leiden University, Leiden University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: Patients: - Mentally capable and older than 18 years old; - Diagnosis of diabetes type-2 - Take metformin as a treatment and/or participate in a lifestyle intervention (e.g., diet) to control their diabetes. Healthy controls: - Mentally capable and older than 18 years old;
Exclusion criteria
Exclusion criteria: Patients: - 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. Healthy controls: - Diagnosis of diabetes type-1 or type-2 - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters are blood insulin and glucose levels during the evocation day in the conditioned patient group versus the control patient group. Separate analyses will be run for each outcome (insulin and glucose). Repeated measures ANCOVA will be used to compare the conditioned and control groups on 7 blood measurements (insulin and glucose separately), controlling for the baseline measurement. In case of a large amount of missing data or large variations in the timing of blood draws, the linear-mixed effects model approach will be applied to the analysis. February 23, 2022: The data collection has been finished. The full data for 62 out of 64 participants is available for the main outcome measures. Two blood samples from one participant and one blood sample from another participant are missing due to problems with blood collection. The Repeated Measures ANCOVA, that was reported as a primary analysis, is sensitive to missing values, and it would exclude the participants with missing blood samples. Therefore, we will perform the linear-mixed effects analysis (as reported in the first version of the pre-registration in case of presence of missing values). The linear mixed-effects model will be equivalent to the pre-registered repeated-measures ANCOVA. The analysis will include baseline blood measures, group (patients versus healthy controls), condition (conditioned versus control), time and the interaction between these variables as fixed effects. Random intercept per participant and random slopes per group will be included into the model in case they improve the model fit. Additional models will be performed with sex as a fixed factor to investigate possible sex differences in the effects in insulin and conditioning. Separate models will be performed for day 1 and day 2 and for each of the outcome repeated measures: blood glucose, insulin, c-peptide, and hunger. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Insulin and glucose levels during the evocation day in the conditioned healthy volunteers versus control healthy volunteers groups. 2. C-peptide levels during the evocation day in the conditioned patient group versus the control patient group; and conditioned healthy volunteers group versus the control healthy volunteers group. 3. Insulin, glucose and C-peptide levels during the acquisition day in the conditioned patient group versus the control patient group; and conditioned healthy volunteers group versus the control healthy volunteers group. 4. Hunger during the acquisition and evocation day in the 4 groups. 5. Memory (immediate and delayed recall) during the acquisition and evocation day in the 4 groups. 6. Approach-avoidance tendencies towards food during the acquisition and evocation day in the 4 groups 7. Food consumption at the end of the acquisition and evocation day in the 4 groups. | — |
Contacts
Public ContactAndrea Evers
Leiden University
Outcome results
None listed