Endogenous Opioid Activity and Affective State in Insulin Resistant Women
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 38
Inclusion Criteria
- Women with mild or moderate depressive symptoms not meeting the criteria for Major Depressive Disorder will be included.
- 18-40 years old
- Women
- ...
- Women with mild or moderate depressive symptoms not meeting the criteria for Major Depressive Disorder will be included.
- 18-40 years old
- Women
- metabolically healthy or insulin resistant (insulin sensitivity > 1.89x10-4 (min-1 x µU-1 x mL-1; calculated by minimal model assessment of glucose tolerance test)
- body mass index (BMI = weight (kg) / height2 (m2)) between 18 kg/m2 and 35 kg/m2.
Exclusion Criteria
- smoking within 6 months
- MRI contraindications (claustrophobia, pacemakers, pumps, metallic agents or devices)
- opioid allergy
- ...
- smoking within 6 months
- MRI contraindications (claustrophobia, pacemakers, pumps, metallic agents or devices)
- opioid allergy
- neurological disease
- BMI ≥35 kg/m2
- uncorrected thyroid disease
- diabetes (fasting glucose ≥126 mg/dL)\
- hormonal, insulin sensitizing, or centrally acting medications within 2 months
- men
- intense physical exercise ≥1 hour/day
- left handed
- major depression
- acute medical illness
- lactation
- cardiac or pulmonary insufficiency
- liver or renal insufficiency (>2.5 x normal transaminases levels, plasma creatinine ≥1.4 mg/dL)
- substance abuse
- severe calorie restriction
- pregnancy within 6 months
- history of lactic acidosis
Summary
- Conditions
- Depression
- Insulin Resistance
- Metabolic Syndrome
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 40 years
- Gender
- Only females
Description
The objective of this study is to examine the role of the endogenous mu-opioid system in mediating the relationship between metabolic dysfunction and depressive symptoms in reproductive aged women. PET image data was unable to be analyzed due to PET equipment replacement midway through study, leavin...
The objective of this study is to examine the role of the endogenous mu-opioid system in mediating the relationship between metabolic dysfunction and depressive symptoms in reproductive aged women. PET image data was unable to be analyzed due to PET equipment replacement midway through study, leaving PET images collected at beginning of study incompatible with PET images collected later in study. Due to insufficient enrollment in treatment arms, the 20 or 40 week data was unusable for analytic goals, so the study was re-framed for what could usefully be learned about baseline characteristics among the study populations and the originally planned outcome measures were amended to only to those that related to understanding the baseline population.
Inclusion Criteria
- Women with mild or moderate depressive symptoms not meeting the criteria for Major Depressive Disorder will be included.
- 18-40 years old
- Women
- ...
- Women with mild or moderate depressive symptoms not meeting the criteria for Major Depressive Disorder will be included.
- 18-40 years old
- Women
- metabolically healthy or insulin resistant (insulin sensitivity > 1.89x10-4 (min-1 x µU-1 x mL-1; calculated by minimal model assessment of glucose tolerance test)
- body mass index (BMI = weight (kg) / height2 (m2)) between 18 kg/m2 and 35 kg/m2.
Exclusion Criteria
- smoking within 6 months
- MRI contraindications (claustrophobia, pacemakers, pumps, metallic agents or devices)
- opioid allergy
- ...
- smoking within 6 months
- MRI contraindications (claustrophobia, pacemakers, pumps, metallic agents or devices)
- opioid allergy
- neurological disease
- BMI ≥35 kg/m2
- uncorrected thyroid disease
- diabetes (fasting glucose ≥126 mg/dL)\
- hormonal, insulin sensitizing, or centrally acting medications within 2 months
- men
- intense physical exercise ≥1 hour/day
- left handed
- major depression
- acute medical illness
- lactation
- cardiac or pulmonary insufficiency
- liver or renal insufficiency (>2.5 x normal transaminases levels, plasma creatinine ≥1.4 mg/dL)
- substance abuse
- severe calorie restriction
- pregnancy within 6 months
- history of lactic acidosis
Tracking Information
- NCT #
- NCT02069379
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Principal Investigator: Alison Berent-Spillson, PhD University of Michigan
- Alison Berent-Spillson, PhD University of Michigan
Get Well Soon