A pilot study to investigate the use of dexamphetamine to treat obesity complicated by diabetes or obstructive sleep apnoea

Not Applicable

• Conditions: Obesity; Obstructive sleep apnoea; Type 2 diabetes; Diet and Nutrition - Obesity; Respiratory - Sleep apnoea; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12613000727741
• Lead Sponsor: epean Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

BMI greater than 30
and either obstructive sleep apnoea on PAP
or Type 2 diabetes mellitus

Exclusion Criteria

History of addiction to illicit drugs, uncontrolled hypertension greater than 140/90, symptomatic ischaemic heart disease, significant kidney or liver disease, uncontrolled epilepsy, weight change of more than 3kg the past 3 months, breastfeeding, pregnant or planning pregnancy, history of bariatric surgery, current depression or other psychiatric illness, current treatment with psychotropic medication, systemic glucocorticoids or medication for weight loss (eg orlistat), family history of sudden death from cardiac causes, hypersensitivity to dexamphetamine or any components of the tablet.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight loss<br>Difference between weight at baseline and weight at 6 months. Weight measured using electronic scales[After 6 months of treatment];Change in apnoea-hypopnoea index (AHI)<br>The AHI is defined as the number of apnoeas or hypopnoeas occurring during 1 hour of sleep. (ie the units are events/hour sleep)<br>An apnoea is defined as an event if there is a 90% reduction in airflow at baseline lasting for at least 10 sec. A Hypopnoea is 30% reduction in airflow at baseline lasting for at least 10 sec with a 3% desaturation of oxygen.<br>[After 6 months of treatment];Change in insulin requirement<br>Participants will be asked their daily insulin requirement at baseline and at 6 months and the change calculated[After 6 months of treatment]

Secondary Outcome Measures

Name	Time	Method
Change in weight after ceasing treatment<br>Difference between weight at 6 months on ceasing treatment and weight at 12 months. Weight measured using electronic scales[12 months];Changes in regular medications<br>Participants will be asked their daily regular medications at baseline and at 6 months and the changes documented[At 6 months]