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Stress Effects on Blood Sugar in Pregnancy (PREDIP Trial)

N/A
Recruiting
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-diabetic and normal result on a random peripheral blood glucose test at the screening visit (<200 mg/dl)
18-22 week's gestation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 hours
Awards & highlights

PREDIP Trial Summary

This trial will study how a mother's emotional state after a controlled stress exposure during pregnancy affects her blood sugar and insulin levels after eating. The effects of emotional state on blood sugar and insulin will be compared after eating a healthy meal (low GI) and a less healthy meal (high GI).

Who is the study for?
This trial is for pregnant women between 18-22 weeks of gestation, with a pre-pregnancy BMI of 25.0-39.9 kg/m2, who are non-diabetic, non-smokers, and fluent in English or Spanish. It excludes those with certain obstetric conditions, psychiatric disorders or treatments, smokers, multiple pregnancies, and those on specific medications affecting metabolism.Check my eligibility
What is being tested?
The study examines how stress affects blood sugar and insulin levels after eating during pregnancy. Participants will be exposed to controlled stress and then given meals varying in healthiness (low vs high GI) to see if emotional state influences post-meal blood glucose and insulin differently.See study design
What are the potential side effects?
Since the interventions involve psychological stress exposure and consumption of standardized meals without medicinal products or invasive procedures involved, significant side effects are not anticipated as part of this trial.

PREDIP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not diabetic and my blood sugar was below 200 mg/dl during the screening.
Select...
I am between 18 to 22 weeks pregnant.

PREDIP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postprandial glycemic response
Secondary outcome measures
Postprandial inflammatory response
Postprandial lipid response
Postprandial metabolic response to stress by meal type

PREDIP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Psychosocial stressExperimental Treatment1 Intervention
Participants will complete the Trier Social Stress Test (TSST) immediately following consumption of their assigned meal type (low or high GI).
Group II: Control non-stressActive Control1 Intervention
Participants will complete a non-stress relaxed task immediately following consumption of their assigned meal type (low or high GI).

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
542 Previous Clinical Trials
1,921,921 Total Patients Enrolled

Media Library

Psychosocial stress Clinical Trial Eligibility Overview. Trial Name: NCT04430439 — N/A
Stress Research Study Groups: Control non-stress, Psychosocial stress
Stress Clinical Trial 2023: Psychosocial stress Highlights & Side Effects. Trial Name: NCT04430439 — N/A
Psychosocial stress 2023 Treatment Timeline for Medical Study. Trial Name: NCT04430439 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility requirements for participating in this research project?

"The prerequisites for entering this medical trial are distress, psychological acuity and being between the ages of 18-40. A total of 80 patients will be allowed into the study."

Answered by AI

Is this trial recruiting participants at present?

"According to data archived on clinicaltrials.gov, this medical study is currently accepting applications for participation since its initial posting in May 2021 and subsequent update in May 2022."

Answered by AI

Is participation in this trial restricted to individuals over the age of eighteen?

"Patients between 18 and 40 years of age are eligible for this medical trial, while those under 18 or over 65 can look up 84 and 397 studies respectively."

Answered by AI

To what extent is the scope of this research inclusive in terms of participant numbers?

"Affirmative. According to clinicaltrials.gov, the study which was first posted on May 11th 2021 is actively enrolling patients at this time. Additionally, 80 persons must be recruited from two distinct medical facilities."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
University of California, Irvine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Emotion-Diet Interactions in Pregnancy
Karen Lindsay 2021. "Emotion-Diet Interactions in Pregnancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04430439.
All > Pregnancy
~20 spots leftby Apr 2025
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