Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients

Plain-language guide to NCT00652379: not phased randomized trial of Octreotide and Lanreotide, insulin resistance, prediabetes & type 2 diabetes, 18 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00652379
Phase: not phased
Status: completed
Start: 2008-06
Completion (planned or actual): 2009-11
Participants: 18 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Acromegaly; Insulin Resistance; Impaired Glucose Tolerance
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Octreotide and Lanreotide for insulin resistance, prediabetes & type 2 diabetes.

Second to investigate body composition, substrate metabolism, symptoms, intrahepatic and intramyocellular fat.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

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 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age \> 18. Diagnosed with acromegaly.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: diabetes mellitus type i; magnetic or electronic implants.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Octreotide group and the comparison group ran side by side rather than switching.

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2008-06 with completion listed for 2009-11.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Insulin sensitivity (time frame: 0 and after 24 weeks).

It also tracked 4 secondary outcomes, for example Glucose tolerance, Symptoms, QoL questionaire, Intrahepatic and intramyocellular fat and Substrate metabolism.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Octreotide and Lanreotide in 18 people with insulin resistance, prediabetes & type 2 diabetes.

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 Octreotide compound page and the Lanreotide compound page, Insulin resistance, prediabetes & type 2 diabetes research.

Our Notes on the Compounds

Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.

Lanreotide: A long-acting 8-amino-acid somatostatin analog (Somatuline Depot) in the same class as octreotide.

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.