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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON32534

Enrollment

180

Registered

2008-11-25

Start date

2008-12-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes diabetes mellitus type 2

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Patients with type 2 diabetes mellitus who will start with insulin therapy • Age 18-85 years • Baseline HbA1c

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The primary objective of the proposed study is to detect an association between energy expenditure and weight gain in insulin-induced weight gain in type 2 diabetes mellitus.	—

Secondary

Measure	Time frame
Furthermore, it is hypothesised that patients who suffer most from insulin-induced weight gain will have: 1) higher caloric intake 2) higher inflammatory markers 3) lower fat hormones 4) body composition: more (trunk) fat	—

Countries

Netherlands

Outcome results