Insulin ResistanceNCT01011062
Effect of Angiotensin Receptor Blockade on Insulin Resistance and Adipose Tissue Cytokines in Type 2 Diabetes
A study testing Hyperinsulinaemia, Losartan and Saline in people with Insulin Resistance and Type 2 Diabetes, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial summary
The study aims to investigate the effect of acute angiotensin receptor blockade on insulin action/insulin resistance and expressions of selected adipocytokines in subcutaneous adipose tissue in insulin-resistant subjects with type 2 diabetes and healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Type 2 Diabetes
- What is being tested?
- Hyperinsulinaemia, Losartan and Saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2004to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes treated with oral agents and/or diet
- Healthy volunteers age- and sex-matched to type 2 diabetes, without any concomitant disease
Who cannot join
- Type 2 Diabetes
- treated with insulin
- clinical evidence of atherosclerotic complications
- advanced long-term diabetic complications (manifest nephropathy, proliferative retinopathy)
- other internal disease
- weight change >10% 3 months prior to study
Show all 9Show fewer
- Healthy volunteers
- fulfilling the criteria of metabolic syndrome
- weight change >10% 3 months prior to study
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Diabetes Center, Institute of Clinical and Experimental Medicine
Prague, 14021
About this study
Official title: Effect of Acute Angiotensin Receptor Blockade on Insulin Resistance and Selected Cytokines in Adipose Tissue in Type 2 Diabetes
The study aims to investigate the effect of acute angiotensin receptor blockade on insulin action/insulin resistance and expressions of selected adipocytokines in subcutaneous adipose tissue in insulin-resistant subjects with type 2 diabetes and healthy controls.
Hypothesis: Changes in adipocytokine concentrations and/or expressions and different reactions to acute in vivo induced hyperinsulinemia and angiotensin receptor blockade will be found in patients with type 2 diabetes compared to healthy subjects. A significant relationships between insulin sensitivity and selected adipokines and intracellular fat content and high energy phosphates in soleus muscle will be documented in healthy individuals, while no significant relation will be found in patients with type 2 diabetes.
Read the detailed description
10-15 patients with type 2 diabetes and 10-15 healthy control subjects will be examined on an outpatient basis. The following examination will be carried out in each subject after 12 hrs fasting:
- Oral glucose tolerance test (75 g of glucose) (in healthy subjects to confirm the normal tolerance of glucose).
- Evaluation of insulin secretion after 1 mg of glucagon i.v.
- Hyperinsulinaemic (75 milly-international unit(mIU)/l) euglycemic clamp study lasting 4 hours combined with indirect calorimetry and biopsy of subcutaneous adipose tissue.
- Hyperinsulinemic (75 mIU/l) euglycemic clamp study lasting 4 hours combined with indirect calorimetry after losartan 100 mg given in the evening and in the morning before the study.
- Proton and phosphorus magnetic resonance spectroscopy.
Before (0 min), at 30 min and in the end of studies c) and d) the blood samples will be taken and biopsies of subcutaneous abdominal adipose tissue will be done.
- Conditions
- Insulin Resistance, Type 2 Diabetes
- Being tested
- Hyperinsulinaemia, Losartan, Saline
- Keywords
- Adipose tissue, Adipokines
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperinsulinaemiaProcedure or surgery
Hyperinsulinaemic (1 mIU/kg/min) euglycaemic (5 mmol/l) clamp
LosartanDrug
Acute administration of losartan 200mg total prior to clamp
SalineDrug
Infusion of Saline as a volume control intervention
| Study group | Role | What they receive |
|---|---|---|
| Hyperinsulinaemia | Experimental | Hyperinsulinaemic (1 mIU/kg/min) euglycaemic (5 mmol/l) clamp Receives: Procedure: Hyperinsulinaemia |
| Losartan + hyperinsulinaemia | Experimental | Not described Receives: Procedure: Hyperinsulinaemia; Drug: Losartan |
| Saline | Placebo comparator | Infusion of Saline as a volume control intervention Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity measured as glucose disposal during clamp
Measured: 4 hours
Secondary outcomes (1)
plasma adipokines and their expressions in SAT
Measured: at 0 and 240 min of the clamp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startJan 2004
- Primary completionOct 2007
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, Czech Republic
- Investigators
- Terezie Pelikanova, Prof., MD, Principal investigator, Diabetes Center, Institute of Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011062
- Sponsor's protocol ID
- CDS01
- Status last verified
- Nov 2009
- First submitted
- 10 Nov 2009
- Last updated
- 18 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acute Angiotensin Receptor Blockade on Insulin Resistance and Selected Cytokines in Adipose Tissue in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01011062
- Acronym / sponsor ID
- CDS01
- Conditions
- Insulin Resistance, Type 2 Diabetes
- Keywords
- Adipose tissue, Adipokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Collaborators
- Ministry of Health, Czech Republic
- Study start
- Jan 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to investigate the effect of acute angiotensin receptor blockade on insulin action/insulin resistance and expressions of selected adipocytokines in subcutaneous adipose tissue in insulin-resistant subjects with type 2 diabetes and healthy controls.
Hypothesis: Changes in adipocytokine concentrations and/or expressions and different reactions to acute in vivo induced hyperinsulinemia and angiotensin receptor blockade will be found in patients with type 2 diabetes compared to healthy subjects. A significant relationships between insulin sensitivity and selected adipokines and intracellular fat content and high energy phosphates in soleus muscle will be documented in healthy individuals, while no significant relation will be found in patients with type 2 diabetes.
Detailed description
10-15 patients with type 2 diabetes and 10-15 healthy control subjects will be examined on an outpatient basis. The following examination will be carried out in each subject after 12 hrs fasting:
- Oral glucose tolerance test (75 g of glucose) (in healthy subjects to confirm the normal tolerance of glucose).
- Evaluation of insulin secretion after 1 mg of glucagon i.v.
- Hyperinsulinaemic (75 milly-international unit(mIU)/l) euglycemic clamp study lasting 4 hours combined with indirect calorimetry and biopsy of subcutaneous adipose tissue.
- Hyperinsulinemic (75 mIU/l) euglycemic clamp study lasting 4 hours combined with indirect calorimetry after losartan 100 mg given in the evening and in the morning before the study.
- Proton and phosphorus magnetic resonance spectroscopy.
Before (0 min), at 30 min and in the end of studies c) and d) the blood samples will be taken and biopsies of subcutaneous abdominal adipose tissue will be done.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyperinsulinaemia | Experimental | Procedure: HyperinsulinaemiaHyperinsulinaemic (1 mIU/kg/min) euglycaemic (5 mmol/l) clamp |
| Losartan + hyperinsulinaemia | Experimental | Procedure: Hyperinsulinaemia, Drug: Losartan |
| Saline | Placebo comparator | Drug: SalineInfusion of Saline as a volume control intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 Diabetes treated with oral agents and/or diet
- Healthy volunteers age- and sex-matched to type 2 diabetes, without any concomitant disease
Key exclusion criteria (9 listed)
- Type 2 Diabetes
- Healthy volunteers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyperinsulinaemiaHyperinsulinaemic (1 mIU/kg/min) euglycaemic (5 mmol/l) clamp | Procedure or surgery | Hyperinsulinaemia, Losartan + hyperinsulinaemia |
| LosartanAcute administration of losartan 200mg total prior to clamp | Drug | Losartan + hyperinsulinaemia |
| SalineInfusion of Saline as a volume control intervention | Drug | Saline |
Primary outcome
insulin sensitivity measured as glucose disposal during clamp
Time frame: 4 hours
1 secondary outcome
plasma adipokines and their expressions in SAT
Time frame: at 0 and 240 min of the clamp
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2013.
Related trials for Insulin Resistance
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terezie Pelikanova, Prof., MD principal investigator
Diabetes Center, Institute of Clinical and Experimental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperinsulinaemia, Losartan and Saline in people with Insulin Resistance and Type 2 Diabetes, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insulin sensitivity measured as glucose disposal during clamp (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2013.