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The Effect of Hyperglycemia on LV Function and Exercise Capacity in Diabetics With and Without Heart Failure.
Plain-language guide to NCT01071772: phase 2 randomized trial of Insulin (regular human), 18 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01071772
- Phase
- phase 2
- Status
- completed
- Start
- 2009-04
- Completion (planned or actual)
- 2010-07
- Participants
- 18 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Heart Failure; Type 2 Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Insulin (regular human).
However it is uncertain how short term diabetic dysregulation in type 2 diabetics affect cardiac function.
It had two arms (groups): euglycemia (experimental) and hyperglycemia (experimental).
The registry classes the interventions as drug.
Who Took Part
18 actual participants took part.
It was open to people of any sex aged from 30 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Insulin treated type 2.
The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: advanced renal disease (creatinine levels \>220 mm); advanced lever disease (alanine aminotransferase \> 3 times over reference level).
How the Study Was Run
It was run as a randomized, crossover and open-label study.
Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.
Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.
Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.
It started in 2009-04 with completion listed for 2010-07.
It ran at 1 site in Denmark.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: 1: Cardiac systolic (EF by 2D and 3D echocardiography) and diastolic (e´/E and E/A) function before and after exercise (time frame: 1-4 weeks). Exercise capacity (time frame: 1-4 months).
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 18 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin (regular human) compound page, all human trials.
Our Notes on the Compound
Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.