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Management of Type 2 Diabetes After Gastric Bypass Surgery
Plain-language guide to NCT01213563: not phased randomized trial of Insulin (regular human), 50 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01213563
- Phase
- not phased
- Status
- terminated early
- Start
- 2009-01
- Completion (planned or actual)
- 2010-09
- Participants
- 50 (actual)
- Design
- randomized, single-blind, supportive_care
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Insulin (regular human).
It had two arms (groups): Actrapid insulin (experimental) and Actrapid insulin+Gloucose (active comparator).
Intensive glycaemic control Intervention: Actrapid insulin.
Conventional glycaemic control Intervention: Actrapid insulin+Glucose.
The registry classes the interventions as drug.
More on the Plan
This is a prospective randomised controlled intervention study on obese human subjects with Type 2 Diabetes Mellitus undergoing obesity surgery (n=80).
Patients will be randomised to either of two treatment protocols.
Protocol A-Conservative Management: On admission to hospital all pre-operative oral antidiabetic agents and insulin are stopped and glucose monitoring is carried out every four hours at the same time as routine observations.
Actrapid insulin is administered with glucose as per standard sliding scale (Appendix A).
Who Took Part
50 actual participants took part.
It was open to people of any sex aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Body mass index (BMI) \> 35,. Having undergone gastric bypass surgery,.
The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: non-insulin requiring t2dm,.
How the Study Was Run
Design: randomized, parallel-group and single-blind.
Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the participants stayed in one arm throughout.
In this single-blind Insulin (regular human) study one party knew the assignments and the other did not.
Those kept unaware of assignments: participant.
It started in 2009-01 with completion listed for 2010-09.
It ran at 1 site in United Kingdom.
Its stated primary purpose is supportive care.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Insulin (regular human) in 50 people.
It ended early (terminated); 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.