Determinants of insulin-induced weight gain in patients with type 2 diabetes mellitus, a prospective study on body compostion, physical activity and metabolic markers

Recruiting

• Conditions: diabetes; diabetes mellitus type 2; 10012653

• Registration Number: NL-OMON32534
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

• Patients with type 2 diabetes mellitus who will start with insulin therapy
• Age 18-85 years
• Baseline HbA1c < 12.0%
• Written informed consent

Exclusion Criteria

• Clinical evidence of psychiatric, renal, cardiovascular or liver or other diseases which may influence study results regarding glucose and weight.
• Patients with hormonal disorders which may influence weight (i.e. thyroid diseases), unless properly treated with stable hormonal levels.
• Excessive alcohol consumption (>20 g/day), and drug abuse
• Use of thiazolidinedione derivatives (TZDs)
• Pregnancy or intention to become pregnant during the study

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the proposed study is to detect an association between<br /><br>energy expenditure and weight gain in insulin-induced weight gain in type 2<br /><br>diabetes mellitus. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Furthermore, it is hypothesised that patients who suffer most from<br /><br>insulin-induced weight gain will have:<br /><br>1) higher caloric intake<br /><br>2) higher inflammatory markers<br /><br>3) lower fat hormones<br /><br>4) body composition: more (trunk) fat</p><br>