Childhood ObesityPhase 4NCT06266598
Effectiveness of Antidiabetic Treatment Applied in Childhood Obesity
A Phase 4 study testing Metformin in people with Childhood Obesity and Insulin Resistance, run by HÜMEYRA ACIKAN at 1 site in Turkey (Türkiye).
Trial summary
In our study, there are 33 healthy children with normal weight (control group) and 52 obese children who will be treated with metformin. To observe the efficacy of the 3-month treatment before and after metformin treatment, Zn, Zinc α-2 Glycoprotein (ZAG), Peroxisome proliferation activating receptor γ (PPARγ), Leptin… Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Insulin Resistance
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Nov 2019to 27 Oct 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Body mass index (BMI) > 95th percentile
- Having insulin resistance
- Having a family history of Type 2 diabetes mellitus (T2DM)
Who cannot join
- Alcohol consumption and smoking
- Having T1DM and T2DM
- History of drug use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Anti-diabetic Treatment Applied in Childhood Obesity on Zinc, Zinc α-2 Glycoprotein and Peroxisome Proliferation Activating Receptor-γ Levels
In our study, there are 33 healthy children with normal weight (control group) and 52 obese children who will be treated with metformin. To observe the efficacy of the 3-month treatment before and after metformin treatment, Zn, Zinc α-2 Glycoprotein (ZAG), Peroxisome proliferation activating receptor γ (PPARγ), Leptin (LEP) and Adiponectin (ADIPO) levels were compared, as well as anthropometric measurements and routine biochemistry tests.
- Conditions
- Childhood Obesity, Insulin Resistance
- Being tested
- Metformin
- Keywords
- Obesity, Metformin, Biomarker
- Medical subject headings
- Pediatric Obesity, Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Only obese children with insulin resistance were treated with metformin.
| Study group | Role | What they receive |
|---|---|---|
| obesity | Other | Children with obesity were recommended to have a diet appropriate for their age and gender and exercise at least 3 days a week for at least 60 minutes each time.
All obese children under the age of 14 were started on metformin treatment at 1000 mg (500 mgx2) per day, and children over this age were started on metformin treatment at the adult dose of 2000 mg (1000 mgx2) per day. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance (HOMA-IR) level
HOMA-IR is a condition in which the body's cells become less responsive to the effects of insulin. This means that the body needs more insulin to achieve the same effects, such as regulating blood sugar levels
Measured: three months
Weight loss rate
Weight loss rate is typically defined as the amount of weight lost over a specific period of time.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start17 Nov 2019
- Primary completion20 Aug 2021
- Study completion27 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In our study, there are 33 healthy children with normal weight (control group) and 52 obese children who will be treated with metformin. To observe the efficacy of the 3-month treatment before and after metformin treatment, Zn, Zinc α-2 Glycoprotein (ZAG), Peroxisome proliferation activating receptor γ (PPARγ), Leptin (LEP) and Adiponectin (ADIPO) levels were compared, as well as anthropometric measurements and routine biochemistry tests.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- HÜMEYRA ACIKAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, HÜMEYRA ACIKAN, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266598
- Sponsor's protocol ID
- EU-TF-HA-01
- Status last verified
- Feb 2024
- First submitted
- 11 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Acikan H, Isik A, Sarikaya E, Muhtaroglu S, Hatipoglu N. The role of short-term metformin in regulating zinc and adipose tissue-derived biomarkers in children with obesity and insulin resistance. BMC Endocr Disord. 2026 Jan 7;26(1):36. doi: 10.1186/s12902-025-02159-w.
PubMed 41501800
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anti-diabetic Treatment Applied in Childhood Obesity on Zinc, Zinc α-2 Glycoprotein and Peroxisome Proliferation Activating Receptor-γ Levels
- ClinicalTrials.gov ID
- NCT06266598
- Acronym / sponsor ID
- EU-TF-HA-01
- Conditions
- Childhood Obesity, Insulin Resistance
- Keywords
- Obesity, Metformin, Biomarker
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- HÜMEYRA ACIKANUniversity, hospital or other
- Study start
- 17 Nov 2019 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In our study, there are 33 healthy children with normal weight (control group) and 52 obese children who will be treated with metformin. To observe the efficacy of the 3-month treatment before and after metformin treatment, Zn, Zinc α-2 Glycoprotein (ZAG), Peroxisome proliferation activating receptor γ (PPARγ), Leptin (LEP) and Adiponectin (ADIPO) levels were compared, as well as anthropometric measurements and routine biochemistry tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In our study, there are 33 healthy children with normal weight (control group) and 52 obese children who will be treated with metformin. To observe the efficacy of the 3-month treatment before and after metformin treatment, Zn, Zinc α-2 Glycoprotein (ZAG), Peroxisome proliferation activating receptor γ (PPARγ), Leptin (LEP) and Adiponectin (ADIPO) levels were compared, as well as anthropometric measurements and routine biochemistry tests.
| Arm | Type | Receives |
|---|---|---|
| obesity | Other | Drug: MetforminChildren with obesity were recommended to have a diet appropriate for their age and gender and exercise at least 3 days a week for at least 60 minutes each time. All obese children under the age of 14 were started on metformin treatment at 1000 mg (500 mgx2) per day, and children over this age were started on metformin treatment at the adult dose of 2000 mg (1000 mgx2) per day. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) > 95th percentile
- Having insulin resistance
- Having a family history of Type 2 diabetes mellitus (T2DM)
Key exclusion criteria (3 listed)
- Alcohol consumption and smoking
- Having T1DM and T2DM
- History of drug use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminOnly obese children with insulin resistance were treated with metformin. | Drug | obesity |
Primary outcome
Insulin resistance (HOMA-IR) level
Time frame: three months
HOMA-IR is a condition in which the body's cells become less responsive to the effects of insulin. This means that the body needs more insulin to achieve the same effects, such as regulating blood sugar levels
Weight loss rate
Time frame: three months
Weight loss rate is typically defined as the amount of weight lost over a specific period of time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 41501800Acikan H, Isik A, Sarikaya E, Muhtaroglu S, Hatipoglu N. The role of short-term metformin in regulating zinc and adipose tissue-derived biomarkers in children with obesity and insulin resistance. BMC Endocr Disord. 2026 Jan 7;26(1):36. doi: 10.1186/s12902-025-02159-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin in people with Childhood Obesity and Insulin Resistance, run by HÜMEYRA ACIKAN at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin resistance (HOMA-IR) level (time frame: three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06266598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.