Recruitment

Recruitment Status
Completed
Estimated Enrollment
38

Inclusion Criteria

Women
18-40 years old
body mass index (BMI = weight (kg) / height2 (m2)) between 18 kg/m2 and 35 kg/m2.
...
Women
18-40 years old
body mass index (BMI = weight (kg) / height2 (m2)) between 18 kg/m2 and 35 kg/m2.
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)
Women with mild or moderate depressive symptoms not meeting the criteria for Major Depressive Disorder will be included.

Exclusion Criteria

men
neurological disease
MRI contraindications (claustrophobia, pacemakers, pumps, metallic agents or devices)
...
men
neurological disease
MRI contraindications (claustrophobia, pacemakers, pumps, metallic agents or devices)
opioid allergy
history of lactic acidosis
severe calorie restriction
pregnancy within 6 months
lactation
intense physical exercise ≥1 hour/day
major depression
uncorrected thyroid disease
BMI ≥35 kg/m2
liver or renal insufficiency (>2.5 x normal transaminases levels, plasma creatinine ≥1.4 mg/dL)
substance abuse
smoking within 6 months
left handed
diabetes (fasting glucose ≥126 mg/dL)\
acute medical illness
cardiac or pulmonary insufficiency
hormonal, insulin sensitizing, or centrally acting medications within 2 months

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
18-40 years old
body mass index (BMI = weight (kg) / height2 (m2)) between 18 kg/m2 and 35 kg/m2.
...
Women
18-40 years old
body mass index (BMI = weight (kg) / height2 (m2)) between 18 kg/m2 and 35 kg/m2.
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)
Women with mild or moderate depressive symptoms not meeting the criteria for Major Depressive Disorder will be included.

Exclusion Criteria

men
neurological disease
MRI contraindications (claustrophobia, pacemakers, pumps, metallic agents or devices)
...
men
neurological disease
MRI contraindications (claustrophobia, pacemakers, pumps, metallic agents or devices)
opioid allergy
history of lactic acidosis
severe calorie restriction
pregnancy within 6 months
lactation
intense physical exercise ≥1 hour/day
major depression
uncorrected thyroid disease
BMI ≥35 kg/m2
liver or renal insufficiency (>2.5 x normal transaminases levels, plasma creatinine ≥1.4 mg/dL)
substance abuse
smoking within 6 months
left handed
diabetes (fasting glucose ≥126 mg/dL)\
acute medical illness
cardiac or pulmonary insufficiency
hormonal, insulin sensitizing, or centrally acting medications within 2 months

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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