Postprandial Hypotension and Insulin Levels

NCT06657287 | Completed

• 1 other identifier: AnkaraYBU-KARAKAYA004
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postprandial Hypotension; Hypoglycemia

Keywords

Hypotension; hypoglycemia; insulin; mixed meal; adults; postprandial

Outcome Measures

Primary Outcomes (3)

• Systolic blood pressure

  mmHg

  During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)

• Blood glucose

  mg/dL

  During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)

• Blood insulin

  uIU/mL

  During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)

Secondary Outcomes (3)

• Blood C-peptide

  During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)

• Diastolic blood pressure

  During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)

• Heart rate

  During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)

Study Arms (1)

Healthy adults

Adults with postprandial symptoms

Other: Mixed meal test

Interventions

Mixed meal test OTHER

The biochemical parameters, blood pressure, and heart rates of participants undergoing the mixed meal test will be recorded over a 5-hour period.

Healthy adults

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Adults with postprandial symptoms

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypoglycemia; Hypotension; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Hyperinsulinism

Study Officials

• Rahime E Karakaya, PhD

  Ankara Yildirim Beyazıt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: April 3, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)