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Conditioning of insulin responses: a high rist- high gain intervention for diabetes type-2

Conditioning of insulin responses: a high rist- high gain intervention for diabetes type-2 - Conditioning of insulin responses

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49422
Enrollment
64
Registered
2018-10-15
Start date
2019-05-27
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes type-2

Interventions

In the experimental 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 t

Sponsors

Universiteit Leiden
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: For patients: - Diagnosis of diabetes mellitus type 2 - Taking metformin or participating in a life style intervention (e.g., diet)

Exclusion criteria

Exclusion criteria: - 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

MeasureTime frame
Main study parameters are blood insulin and glucose levels during the evocation day in the experimental patients group versus the control patients group. Insulin and glucose will be measured 8 times: at baseline, after each of the 6 applications of nasal spray and 15 minutes after the last spray administration.

Secondary

MeasureTime frame
Secondly, we investigate the effects of conditioning with insulin on C-peptide, hunger, approach-avoidance tendencies, food intake and cognitive functioning measured with a memory task. Finally, a comparison between patients and healthy participants will be made on the study outcomes.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)