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Predictive value of beta cell function during eu- and hyperglycemic clamp for changes in BMI, HbA1c and the incidence of hypertension

Predictive value of beta cell function during eu- and hyperglycemic clamp for changes in BMI, HbA1c and the incidence of hypertension - BETAPRO

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57793
Enrollment
130
Registered
2025-06-27
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

diabetes mellitus type 2 glucose disregulation disorder

Interventions

None listed

Sponsors

internal medicine
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)