Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03380325
Other study ID # Bootcamp1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 11, 2016
Est. completion date June 29, 2017

Study information

Verified date July 2019
Source VU University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study examines the effects of iloprost - a stable prostacyclin analogue - on insulin-mediated muscle capillary recruitment and whole-body glucose uptake in a cross-over design.


Description:

In type 2 diabetes impaired insulin-mediated muscle perfusion is thought to contribute to reduced whole-body glucose uptake. This study aims to identify iloprost - a stable prostacyclin analogue - as a possible therapeutic option to increase whole-body glucose uptake via enhancement of muscle perfusion.

All participants will be subjected to two hyperinsulinemic-euglycemic clamps; one with and one without simultaneous iloprost infusion in a randomized cross-over design. Microvascular blood volume will be measured by means of contrast-enhanced ultrasonography.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date June 29, 2017
Est. primary completion date June 29, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Type 2 diabetes

- Male or female (post-menopausal)

- Age above 45 years and below 70 years

- BMI >30 kg/m2

- HbA1c < 80 mmol/mol or < 8,6% Subjects must use metformin

- Stable medication use

- Stable tension regulation (with or without medication)

- Subjects should be able to give informed consent

Exclusion Criteria:

- A history of cardiovascular event (Cerebrovascular event, myocardial infarction or pacemaker implantation)

- Severe-very severe lung emphysema (GOLD stage III-IV)

- Use of any antibiotics or proton pump inhibitor (PPI) in the past three months

- Use of any other antidiabetic medication besides metformin (e.g. SU-derivates, insulin)

- Use of a platelet inhibitor or cumarin derivate during

- Subjects participated in a lifestyle programme in the past 6 months (diet or exercise)

Study Design


Intervention

Drug:
Iloprost infusion
Iloprost is a stable prostacyclin analogue

Locations

Country Name City State
Netherlands VU University Medical Center Amsterdam Noord-Holland

Sponsors (1)

Lead Sponsor Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of disappearance Glucose uptake in peripheral tissues during hyperinsulinemic euglycemic clamp During the clamp
Primary Capillary recruitment Change in skeletal muscle en myocardial microvascular blood volume upon insulin infusion Before and during the clamp
Secondary Continous cardiovascular monitoring Diastolic blood pressure Before and during the clamp
Secondary Continous cardiovascular monitoring Systolic blood pressure Before and during the clamp
Secondary Continous cardiovascular monitoring Cardiac output Before and during the clamp
Secondary Continous cardiovascular monitoring Heart rate Before and during the clamp
Secondary Continous cardiovascular monitoring Stroke volume Before and during the clamp
Secondary Continous cardiovascular monitoring Systemic vascular resistance Before and during the clamp
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT02836704 - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) Phase 4
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Completed NCT04562714 - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy N/A
Completed NCT02009488 - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT05896319 - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2 N/A
Recruiting NCT05598203 - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes N/A
Completed NCT05046873 - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Phase 1
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT04090242 - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes N/A
Completed NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
Completed NCT03604224 - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT03620890 - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy Phase 4
Withdrawn NCT05473286 - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04531631 - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes Phase 2