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Resolution of Type 2 Diabetes Mellitus: Intensive vs. Conventional Glycaemic Control After Obesity Surgery
Plain-language guide to NCT01257087: not phased randomized trial of Insulin (regular human), 35 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01257087
- Phase
- not phased
- Status
- completed
- Start
- 2010-12
- Completion (planned or actual)
- 2016-02
- Participants
- 35 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus; Obesity
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Insulin (regular human).
The investigators do not know whether strict control of blood glucose/sugar after the operation makes any difference in the long term.
It had two arms (groups): Intensive glycaemic control (experimental) and Conservative glycaemic control (active comparator).
The registry classes the interventions as drug.
More on the Plan
Subjects would be randomised into intensive glycaemic control and conventional glycaemic control after obesity surgery.
Data on complications of diabetes such as eye, nerve and kidney will be collected before obesity surgery and 1 year after surgery.
Who Took Part
Enrollment: 35 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients with Type 2 Diabetes Mellitus who have been approved for obesity surgery.
The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: patients with type 2 diabetes mellitus who do not require insulin immediately after obesity surgery.
How the Study Was Run
Design: randomized, parallel-group and open-label.
The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Insulin (regular human) study did not mask who received what.
It started in 2010-12 with completion listed for 2016-02.
It ran at 1 site in United Kingdom.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 2 secondary outcomes, for example Number of Participants With Microvascular Events.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Insulin (regular human) in 35 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.