An efficacy, safety and pharmacokinetic study on the short-term and long-term use of METFORMIN in obese children and adolescents.

An efficacy, safety and pharmacokinetic study on the short-term and long-term use of METFORMIN in obese children and adolescents. - Metformin in obese children and adolescents

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39499

Enrollment

144

Registered

2011-07-07

Start date

2011-08-25

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Bariatrie (Obesitas) excess body fat Obese

Interventions

In the initial study, the study population will be assigned to either placebo or Metformin. All subjects will follow the same lifestyle-intervention program during the entire study period of 18 mont

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria are subject*s age >= 10 and 2.3 and with insulin resistance defined as HOMA-IR >= 3.4. In addition an obtained informed consent from subjects and/or parents/caregivers.

Exclusion criteria

Exclusion criteria: The exclusion criteria are presence of T2DM (American Diabetes Association criteria); presence of endocrine disorders with steroid therapy; suspicion of polycystic ovarium syndrome; height = 150% of normal value for age); use of ritonavir; use of ACE inhibitors; insufficient knowledge of the Dutch language.

Design outcomes

Primary

Measure	Time frame
Primary study endpoint for efficacy is the reduction in BMI, which is calculated from the anthropometric measurements. Other primary endpoints for efficacy are insulin resistance, calculated by the HOMA-IR, which is a generally accepted index to determine insulin resistance in children and adolescents, percentage of body fat measured by bio-impedance, HbA1C value, β-cell function, calculated by HOMA-β%, oral disposition index, insulin secretion calculated by the insulinogenic index, physical fitness measured by validated fitness tests, basal metabolic rate measured by calorimetry and quality of life measured by validated quality of life questionnaire.	—

Measure

Time frame

Primary study endpoint for efficacy is the reduction in BMI, which is calculated from the anthropometric measurements. Other primary endpoints for efficacy are insulin resistance, calculated by the HOMA-IR, which is a generally accepted index to determine insulin resistance in children and adolescents, percentage of body fat measured by bio-impedance, HbA1C value, β-cell function, calculated by HOMA-β%, oral disposition index, insulin secretion calculated by the insulinogenic index, physical fitness measured by validated fitness tests, basal metabolic rate measured by calorimetry and quality of life measured by validated quality of life questionnaire.

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Secondary

Measure	Time frame
Secondary outcome parameters for safety of metformin treatment are hepatic and renal function tests, and for tolerability the number of adverse effects (in relation to the achieved dose level). Tertiary outcome parameters are the pharmacokinetic parameters of metformin in obese children and adolescents. These parameters are estimated using population PK-PD modelling techniques in which a comprehensive covariate analysis will be performed allowing to account for variability in PK parameters on the basis of individual characteristics such as age, bodyweight, BMI, percentage of body fat, gender, Tanner stage and genetic constitution. Quaternary outcome parameters for long-term efficacy and long-term safety and tolerability of metformin are BMI, insulin resistance calculated by the HOMA-IR, percentage of body fat measured by bio-impedance, HbA1C, β-cell function, calculated by HOMA-β%, oral disposition index, insulin secretion calculated by the insulinogenic index, physical fitness measured by validated fitness tests, quality of life measured by validated quality of life questionnaire, hepatic and renal function tests and number of side effects. In addition, the percentage of patients that has developed impaired fasted glucose, impaired glucose tolerance (2-hrs plasma glucose during an OGTT), T2DM and the development of micro-vascular complications detected by micro-albuminuria and macro-vascular complications detected by using pulse wave velocity (PWV) and augmentation index (AIx) is evaluated.	—

Measure

Time frame

Secondary outcome parameters for safety of metformin treatment are hepatic and renal function tests, and for tolerability the number of adverse effects (in relation to the achieved dose level). Tertiary outcome parameters are the pharmacokinetic parameters of metformin in obese children and adolescents. These parameters are estimated using population PK-PD modelling techniques in which a comprehensive covariate analysis will be performed allowing to account for variability in PK parameters on the basis of individual characteristics such as age, bodyweight, BMI, percentage of body fat, gender, Tanner stage and genetic constitution. Quaternary outcome parameters for long-term efficacy and long-term safety and tolerability of metformin are BMI, insulin resistance calculated by the HOMA-IR, percentage of body fat measured by bio-impedance, HbA1C, β-cell function, calculated by HOMA-β%, oral disposition index, insulin secretion calculated by the insulinogenic index, physical fitness measured by validated fitness tests, quality of life measured by validated quality of life questionnaire, hepatic and renal function tests and number of side effects. In addition, the percentage of patients that has developed impaired fasted glucose, impaired glucose tolerance (2-hrs plasma glucose during an OGTT), T2DM and the development of micro-vascular complications detected by micro-albuminuria and macro-vascular complications detected by using pulse wave velocity (PWV) and augmentation index (AIx) is evaluated.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)