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Controlled Blood Sugar Variation for Stress Response (Hypo fMRI Trial)

N/A

Recruiting

Led By Roy Freeman, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and Females age 18 to 45 years

Be between 18 and 65 years old

Must not have

Estimated GFR <60 mL/min/1.73 m2

Use of medications other than thyroid hormone or hormonal birth control

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 8 hours after physiological stress, and 4 days after physiological stress

Summary

This trial will study the effects of low blood sugar on the nervous system to help reveal how non-psychological stress impacts the brain & autonomic nervous system.

Who is the study for?

This trial is for healthy men and women aged 18-45 with a BMI of 18-35. Participants must not have kidney issues, diabetes, severe depression or anxiety, metal implants, be pregnant or lactating, use tobacco or drugs, have abnormal heart readings or take certain medications.

What is being tested?

The study tests how low blood sugar stress affects the nervous system by using two procedures: Normoglycemic Hyperinsulinemic Clamp to maintain normal blood sugar levels and Hypoglycemic Hyperinsulinemic Clamp to lower them.

What are the potential side effects?

Possible side effects include discomfort at the infusion site from clamps used during the procedure. Low blood sugar can cause symptoms like dizziness, sweating, hunger, irritability or confusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is reduced.

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I only use thyroid hormone or hormonal birth control.

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I have gone through menopause.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8 hours after physiological stress, and 4 days after physiological stress

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 8 hours after physiological stress, and 4 days after physiological stress

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 hours after physiological stress, and 4 days after physiological stress for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effect of physiological stress (hypoglycemia) on brain networks involved in autonomic function

The relationship over time between stress-induced changes in brain networks and stress-induced changes in baroreflex sensitivity

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: HypoglycemiaActive Control1 Intervention

Participants undergo Autonomic Nervous System (ANS) Testing (measurement of Baroreflex Sensitivity using the Modified Oxford test) followed by a functional MRI (fMRI) scan. The next day, participants undergo one 120-minute hypoglycemic hyperinsulinemic clamp procedure (50mg/dL) in the morning followed by ANS Testing and an fMRI scan. Four days later, participants undergo repeat ANS Testing and an fMRI scan.

Group II: NormoglycemiaPlacebo Group1 Intervention

Participants undergo Autonomic Nervous System (ANS) Testing (measurement of Baroreflex Sensitivity using the Modified Oxford test) followed by a functional MRI (fMRI) scan. The next day, participants undergo one 120-minute normoglycemic hyperinsulinemic clamp procedure (90mg/dL) in the morning followed by ANS Testing and an fMRI scan. Four days later, participants undergo repeat ANS Testing and an fMRI scan.

0 / 4Eligibility criteria met