Postprandial Hypotension and Insulin Levels

October 23, 2024 updated by: Rahime Evra KARAKAYA, Ankara Yildirim Beyazıt University

Relationship Between Insulin Levels and Postprandial Hypotension in the Standard Mixed Meal Test in Adults

The goal of this observational study is to learn about the relationship between postprandial hypotension and insulin levels in adults. The main question it aims to answer is:

Is the incidence of postprandial hypotension high in patients who undergo mixed meal test?

Is insulin level higher in individuals with postprandial hypotension compared to those without during a mixed meal test?

Patients with postprandial symptoms were scheduled for a mixed meal test, during which plasma glucose, insulin, C-peptide, blood pressure, and heart rate were measured at specific time points.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey, 06800
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who apply to the Endocrinology Clinic of Ankara Bilkent City Hospital.

Description

Inclusion Criteria:

  • Adults with postprandial symptoms

Exclusion Criteria:

  • Individuals with prediabetes or diabetes,
  • Those aged 65 and above,
  • Patients using antihypertensive medications or with known hypertension,
  • Those with active infections,
  • Congestive heart failure,
  • Peripheral artery disease,
  • Advanced-stage dementia,
  • Individuals who could not provide a history or were unable to cooperate,
  • Patients using medications that could induce hypoglycemia (oral antidiabetics, insulin, beta-blockers, hydroxychloroquine, bromocriptine, etc.)
  • Those with conditions that could cause hypoglycemia (uncontrolled hypothyroidism, adrenal insufficiency, growth hormone deficiency, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy adults
Adults with postprandial symptoms
Other: Mixed meal test
The biochemical parameters, blood pressure, and heart rates of participants undergoing the mixed meal test will be recorded over a 5-hour period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
mmHg
During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
Blood glucose
Time Frame: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
mg/dL
During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
Blood insulin
Time Frame: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
uIU/mL
During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood C-peptide
Time Frame: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
ng/mL
During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
Diastolic blood pressure
Time Frame: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
mmHg
During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
Heart rate
Time Frame: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
bpm
During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Yildirim Beyazıt University

Investigators

  • Principal Investigator: Rahime E Karakaya, PhD, Ankara Yildirim Beyazıt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2024

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

October 24, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraYBU-KARAKAYA004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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