NCT05237076

Brief Summary

This trial will assess chemosensitivity differences of the carotid bodies in individuals with T2DM, compared to healthy controls. During baseline and hyperinsulinemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

February 2, 2022

Last Update Submit

May 30, 2023

Conditions

Diabetes Mellitus, Type 2Hypoxia

Outcome Measures

Primary Outcomes (1)

  • Chemosensitivity of carotid bodies during baseline and euglycemic clamp

    L/min/PaO2

    5 minutes

Secondary Outcomes (1)

  • HRV during baseline and euglycemic clamp

    30 min

Study Arms (2)

Diabetes Type 2

EXPERIMENTAL

Patients with DM Type 2 using Oral Diabetes Medications only.

Diagnostic Test: Hyperinsulemic-Euglycemic Clamp & Hypoxic Ventilatory Response (HVR)

Healthy controls

ACTIVE COMPARATOR

Healthy controls without comorbidities.

Diagnostic Test: Hyperinsulemic-Euglycemic Clamp & Hypoxic Ventilatory Response (HVR)

Interventions

Hyperinsulemic-Euglycemic Clamp & Hypoxic Ventilatory Response (HVR)DIAGNOSTIC_TEST

Hyperinsulemic-Euglycemic Clamp as described by deFronzo et al.

Diabetes Type 2Healthy controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • years and older
  • Subjects must be willing to give written informed consent for the trial and able to adhere to dose and visit schedule.
  • Non-insulin-dependent diabetes mellitus (NIDDM) or healthy sex, age (± 3 yrs) and BMI (± 3 kg/m2) matched controls.
  • Have no clinical or electrocardiographic signs of ischemic heart disease as determined by the Investigator with normal cardiac intervals appropriate for their gender. The Screening 12 lead ECG conduction intervals must be within gender specific normal range (e.g., QTcF ≤ 430 msec, PR interval ≤ 220 msec). ECGs are to be judged by the investigator or sub investigator as per standardized procedures.
  • Vital sign measurements must be within the following ranges: (Individuals with values outside (or indicate lower or higher) of these ranges may be enrolled if clinically acceptable to the investigator and sponsor.
  • body temperature, between 35.5°C and 37.5°C
  • systolic blood pressure, 90 to 150 mmHg
  • diastolic blood pressure, 40 to 95 mmHg
  • pulse rate, 40 to 100 bpm
  • Subjects must be free of any clinically significant disease that would interfere with the study evaluations.
  • Subjects presenting out of range values of lab/ECG/vital signs compatible with normal variation of the normal healthy subject can be included in the study at the investigator's discretion and sponsor written approval.
  • Positive Allen's test
  • Fitzpatrick skin type I or II
  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LUMC

Leiden, South Holland, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hypoxia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Albert Dahan, MD, PhD

    LUMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Multi arm pre-post study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2022

First Posted

February 11, 2022

Study Start

December 1, 2021

Primary Completion

August 5, 2022

Study Completion

February 15, 2023

Last Updated

May 31, 2023

Record last verified: 2023-05

Locations

NL(1)