Endogenous Opioid Activity and Affective State in Insulin Resistant Women
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 38
Inclusion Criteria
- body mass index (BMI = weight (kg) / height2 (m2)) between 18 kg/m2 and 35 kg/m2.
- 18-40 years old
- Women
- ...
- body mass index (BMI = weight (kg) / height2 (m2)) between 18 kg/m2 and 35 kg/m2.
- 18-40 years old
- Women
- Women with mild or moderate depressive symptoms not meeting the criteria for Major Depressive Disorder will be included.
- 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)
Exclusion Criteria
- pregnancy within 6 months
- neurological disease
- MRI contraindications (claustrophobia, pacemakers, pumps, metallic agents or devices)
- ...
- pregnancy within 6 months
- neurological disease
- MRI contraindications (claustrophobia, pacemakers, pumps, metallic agents or devices)
- substance abuse
- men
- smoking within 6 months
- acute medical illness
- opioid allergy
- intense physical exercise ≥1 hour/day
- BMI ≥35 kg/m2
- diabetes (fasting glucose ≥126 mg/dL)\
- lactation
- severe calorie restriction
- cardiac or pulmonary insufficiency
- major depression
- uncorrected thyroid disease
- hormonal, insulin sensitizing, or centrally acting medications within 2 months
- liver or renal insufficiency (>2.5 x normal transaminases levels, plasma creatinine ≥1.4 mg/dL)
- history of lactic acidosis
- left handed
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
- body mass index (BMI = weight (kg) / height2 (m2)) between 18 kg/m2 and 35 kg/m2.
- 18-40 years old
- Women
- ...
- body mass index (BMI = weight (kg) / height2 (m2)) between 18 kg/m2 and 35 kg/m2.
- 18-40 years old
- Women
- Women with mild or moderate depressive symptoms not meeting the criteria for Major Depressive Disorder will be included.
- 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)
Exclusion Criteria
- pregnancy within 6 months
- neurological disease
- MRI contraindications (claustrophobia, pacemakers, pumps, metallic agents or devices)
- ...
- pregnancy within 6 months
- neurological disease
- MRI contraindications (claustrophobia, pacemakers, pumps, metallic agents or devices)
- substance abuse
- men
- smoking within 6 months
- acute medical illness
- opioid allergy
- intense physical exercise ≥1 hour/day
- BMI ≥35 kg/m2
- diabetes (fasting glucose ≥126 mg/dL)\
- lactation
- severe calorie restriction
- cardiac or pulmonary insufficiency
- major depression
- uncorrected thyroid disease
- hormonal, insulin sensitizing, or centrally acting medications within 2 months
- liver or renal insufficiency (>2.5 x normal transaminases levels, plasma creatinine ≥1.4 mg/dL)
- history of lactic acidosis
- left handed
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
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