diabetes mellitus type 2 glucose disregulation disorder
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Between September 2004 and the end of 2006 154 families were selected from the NTR on the basis of the presence of a same-sex twin pair and one or more same-sex siblings. Additional inclusion criteria for participation in this study were: no known diabetes mellitus, Caucasian origin, good general health, minimum age for all participants 20 years. The maximum age for twins was 45 years; the same-sex sibling could have a maximal difference of five years with the twin. Of each family, a minimum of two persons (a twin pair or one of the twin pair and a same-sex sibling) had to participate. They all had to sign an informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria for participation were: metabolic disorders as diabetes mellitus, uncontrolled thyroid and/or adrenal disease; use of the following drugs: antiviral, corticosteroids, antihypertensive or other drugs that affect insulin secretion and/or insulin sensitivity; serious heart-, pulmonary-, interfering malignant- or haematological diseases; renal disease/impairment (creatinine >150 mol/l) or hepatic disease (enzyme values > 3 x upper limit of normal). Women who were pregnant or intended to become pregnant within the study period were excluded as well as women in the first six months after child birth. Participants should not have a serious mental impairment i.e. preventing to understand the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Mixed meal parameters 2004-2007 • Clamp parameters 2004-2007 o Insulin sensitivity index (µmol min-1 kg-1 [pmol/l]-1) o Insulin level at t0 of the clamp (pmol/l) o iAUC of glucose stimulated insulin from t1-t10 of clamp (pmol/l) o Second phase iAUC of glucose stimulated insulin (pmol/l) o GLP-1 stimulated iAUC of insulin (pmol/l) o Arginine stimulated iAUC (pmol/l) • HbA1c (%) • Diabetes status | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives include identifying other factors/confounders (e.g. age, sex, BMI, diet) that contribute to the prediction alongside clamp test results and to assess the contribution of genetic and environmental factors to the association between beta-cell function and future diabetic status. • Age • BMI • Diet (DDQ-index) • Hypertensive status • Zygosity data: | — |
Countries
Netherlands