Effect of Weight Loss on Brain Insulin Sensitivity in Humans

University Hospital Tuebingen

Status: Enrolling

Conditions: Insulin Resistance

Treatments: Other: nasal insulin; Other: placebo spray

Study type: Interventional

Funder types: Other

Identifiers

NCT02991365

8 weeks study

Details and patient eligibility

About

Obesity if known to be associated with brain insulin resistance in humans. This condition has not only implication for the brain but also for whole-body energy homeostasis. Research in rodents indicates that weight loss is able to improve insulin sensitivity of the brain. The current project will test this hypothesis in humans. Therefore, brain insulin sensitivity will be assessed by fMRI in combination with intranasal insulin administration, using an established protocol. Furthermore, effects of daily administration of insulin nasal spray (versus placebo) over 8 weeks will be assessed as secondary (exploratory) variables.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• HbA1c <6.5%
• Age between 40 and 75 years
• No intake of antidiabetic drugs or drugs for weight reduction
• no steroid intake
• Stable medication over 10 weeks before the start of the study

Exclusion criteria

• Persons who wear non-removable metal parts in or on the body.
• Persons with reduced temperature sensitivity and / or increased sensitivity to heating of the body
• Cardiovascular disease can not be ruled out, e.g. manifest coronary heart disease, heart failure greater than NYHA 2, previous heart attack, stroke condition
• Persons with hearing impairment or increased sensitivity to loud noises
• People with claustrophobia
• Minors or non-consenting subjects are also excluded
• Subjects with an operation less than 3 months
• Simultaneous participation in other studies
• Neurological and psychiatric disorders
• Subjects with hemoglobin Hb <11 g / dl
• Hypersensitivity to any of the substances used

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

nasal insulin

Active Comparator group

Description:

daily administration of 160 U of human insulin as nasal spray

Treatment:

Other: nasal insulin

placebo spray

Placebo Comparator group

Description:

daily administration of placebo solution as nasal spray

Treatment:

Other: placebo spray