Diabetes Mellitus, Type 2NCT03598738
The Effect of Esomeprazole on Type 2 Diabetes
A study testing Esomeprazole 40mg in people with Diabetes Mellitus, Type 2, run by Baskent University Ankara Hospital.
Trial summary
The investigators aimed to prospectively investigate the effects of esomeprazole on glycaemic control in patients with type 2 diabetes mellitus. The investigators also aimed to associate this effect with gastrin levels. Read more about this study
- Who is it for?
- Ages 47 to 72 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Esomeprazole 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2015to 1 Dec 2017
- Phase
- Interventional
- 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 47 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All the participants that has a diagnosis of T2DM and had at least 1-year follow-up in Endocrinology outpatient clinic.
- All the study participants were chosen from regulated diabetic subjects whose diabetes treatment were not amended.
- In the intervention group, all participants had various degrees of symptoms for functional dyspepsia, gastro-oesophageal reflux, gastritis or duodenitis
- The control group consisted of without gastric complaints, thus who did not receive PPI drugs.
Who cannot join
- We excluded any cases needing revision in their treatment strategies due to ethical issues.
- Subjects, on pioglitazone and incretin-based therapies;
- Subjects with a history of gastrointestinal surgery, liver or kidney disease, diabetic macro- or microvascular complications;
- Subjects who are lactating or pregnant
- Subjects on any PPI treatment or had a history of PPI use in a 3 months period before the study, were excluded.
About this study
Official title: The Effect of Esomeprazole on Gastrin Levels and Glycaemic Regulation of Type 2 Diabetes: A Prospective Trial
The investigators aimed to prospectively investigate the effects of esomeprazole on glycaemic control in patients with type 2 diabetes mellitus. The investigators also aimed to associate this effect with gastrin levels. Thirty-two type 2 diabetes mellitus objects were recruited into intervention (n=16) and control (n=16) groups. The participants in the intervention group were prescribed 40 mg of esomeprazole treatment for three months. At the beginning of the study and at month 3, HbA1c level (%) and gastrin levels (pmol/L) of participants were assessed. Then the baseline and 3rd month data of groups were compared.
Read the detailed description
Thirty-two patients recruited in the study. All the participants had a diagnosis of T2DM and had at least 1-year follow-up in Endocrinology outpatient clinic. All the study participants were chosen from regulated diabetic subjects whose diabetes treatment were not amended. The investigators excluded any cases needing revision in their treatment strategies due to ethical issues. Participants were recruited in intervention and control groups. Each group consisted of 16 diabetic subjects. Groups were matched for age, diabetes duration, body mass index, baseline HbA1c level and gastrin levels. In the intervention group, all participants had various degrees of symptoms for functional dyspepsia, gastro-oesophageal reflux, gastritis or duodenitis and all of them were prescribed 40 mg of esomeprazole treatment for three months. The control group consisted of without gastric complaints, thus who did not receive PPI drugs. This group was followed-up without any intervention for three months. All subjects were advised for dietary recommendations and lifestyle modifications. At the end of the study, all of them reported their adherence to these recommendations. Subjects, on pioglitazone and incretin-based therapies; subjects with a history of gastrointestinal surgery, liver or kidney disease, diabetic macro- or microvascular complications; who are lactating or pregnant, were excluded. Subjects on any PPI treatment or had a history of PPI use in a 3 months period before the study were not eligible.
The height was measured in the standing position with a tape measure fixed on the wall. Body weight, fat mass, and fat percentage were measured using a conventional bioelectrical impedance (BIA) device (TBF-300, Tanita corp., Tokyo, Japan). All measurements were completed after a mean period of 60 seconds. Subjects were asked not to consume alcohol during the 24-hour period before assessment and caffeine for the 4 hours before assessment. All accessories, such as heavy clothing, rings, and earrings, which could affect the measurements, were removed before the assessment. Body mass index was calculated as weight in kilograms divided by the square of the height in meters (kg/m2). All measurements were performed by one physician after the participants had fasted for at least 8 hours. Fasting blood glucose (FBG) (mg/dl.), triglyceride (mg/dL), high-density lipoprotein cholesterol (HDL-c, mg/dL), low-density lipoprotein cholesterol (LDL-c, mg/dL), thyroid-stimulating hormone (TSH) (IU/mL), HbA1c level (%) and gastrin levels (pmol/L) were measured by using a sample of venous blood. TSH assays were performed via immunochemiluminescent assay (Architect c8200, Abbott). FBG, LDL-c, HDL-c, and triglyceride levels were measured by using the hexokinase 7/G-6-PDH method, a measured liquid-selective detergent method, an accelerator-selective detergent method, and a glycerol phosphate oxidase method (Architect c8200, Abbott), respectively. HbA1c was via the enzymatic method using Architect c4000 (Abbott) system from human complete blood and hemolysate. Serum gastrin level was measured by a competitive radioimmunoassay using a rabbit antiserum raised against a gastrin 17 albumin conjugate (DiaSource ImmunoAssasys S.A., Louvain-la-Neuve, Belgium). According to the manufacturer, the range of gastrin level is 11-54 pmol/L and the lowest detectable concentration is 5 pmol/L. All measurements were performed both at baseline and the follow-up visit.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Esomeprazole 40mg
- Keywords
- Esomeprazole, Gastrin, HbA1c, Glycaemic Regulation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole 40mgDrug
Also called Nexium 40 mg
Esomeprazole 40mg oral tablet, once a day
| Study group | Role | What they receive |
|---|---|---|
| Esomeprazole 40mg Group | Active comparator | Intervention group consisted of 16 diabetic subjects that had various degrees of symptoms for functional dyspepsia, gastro-oesophageal reflux, gastritis or duodenitis. All of them were prescribed 40 mg of esomeprazole treatment for three months. Receives: Drug: Esomeprazole 40mg |
| Control Group | No intervention | The control group consisted of without gastric complaints, thus who did not receive PPI drugs. This group was followed-up without any intervention for three months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c change
HbA1c change with esomeprazole in 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Dec 2015
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University Ankara Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf Bozkuş, Baskent University Ankara Hospital
- Investigators
- Yusuf Bozkuş, Assist Prof, Study director, Başkent University Endocrinolgy DepNeslihan Başçıl Tütüncü, Prof, Principal investigator, Başkent University Endocrinolgy DepÖzlem Turhan İyidir, Assoc Prof, Principal investigator, Başkent University Endocrinolgy DepUmut Mousa, Dr, Principal investigator, Başkent University Endocrinolgy DepNazlı Kırnap, Dr, Principal investigator, Başkent University Endocrinolgy DepCanan Çiçek Demir, Dr, Principal investigator, Başkent University Endocrinolgy DepAslı Nar, Assoc Prof, Principal investigator, Başkent University Endocrinolgy Dep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598738
- Sponsor's protocol ID
- KA12/242
- Status last verified
- Jul 2018
- First submitted
- 16 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Esomeprazole on Gastrin Levels and Glycaemic Regulation of Type 2 Diabetes: A Prospective Trial
- ClinicalTrials.gov ID
- NCT03598738
- Acronym / sponsor ID
- KA12/242
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Esomeprazole, Gastrin, HbA1c, Glycaemic Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Baskent University Ankara HospitalUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 26 Jul 2018 (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.
The investigators aimed to prospectively investigate the effects of esomeprazole on glycaemic control in patients with type 2 diabetes mellitus. The investigators also aimed to associate this effect with gastrin levels. Thirty-two type 2 diabetes mellitus objects were recruited into intervention (n=16) and control (n=16) groups. The participants in the intervention group were prescribed 40 mg of esomeprazole treatment for three months. At the beginning of the study and at month 3, HbA1c level (%) and gastrin levels (pmol/L) of participants were assessed. Then the baseline and 3rd month data of groups were compared.
Detailed description
Thirty-two patients recruited in the study. All the participants had a diagnosis of T2DM and had at least 1-year follow-up in Endocrinology outpatient clinic. All the study participants were chosen from regulated diabetic subjects whose diabetes treatment were not amended. The investigators excluded any cases needing revision in their treatment strategies due to ethical issues. Participants were recruited in intervention and control groups. Each group consisted of 16 diabetic subjects. Groups were matched for age, diabetes duration, body mass index, baseline HbA1c level and gastrin levels. In the intervention group, all participants had various degrees of symptoms for functional dyspepsia, gastro-oesophageal reflux, gastritis or duodenitis and all of them were prescribed 40 mg of esomeprazole treatment for three months. The control group consisted of without gastric complaints, thus who did not receive PPI drugs. This group was followed-up without any intervention for three months. All subjects were advised for dietary recommendations and lifestyle modifications. At the end of the study, all of them reported their adherence to these recommendations. Subjects, on pioglitazone and incretin-based therapies; subjects with a history of gastrointestinal surgery, liver or kidney disease, diabetic macro- or microvascular complications; who are lactating or pregnant, were excluded. Subjects on any PPI treatment or had a history of PPI use in a 3 months period before the study were not eligible.
The height was measured in the standing position with a tape measure fixed on the wall. Body weight, fat mass, and fat percentage were measured using a conventional bioelectrical impedance (BIA) device (TBF-300, Tanita corp., Tokyo, Japan). All measurements were completed after a mean period of 60 seconds. Subjects were asked not to consume alcohol during the 24-hour period before assessment and caffeine for the 4 hours before assessment. All accessories, such as heavy clothing, rings, and earrings, which could affect the measurements, were removed before the assessment. Body mass index was calculated as weight in kilograms divided by the square of the height in meters (kg/m2). All measurements were performed by one physician after the participants had fasted for at least 8 hours. Fasting blood glucose (FBG) (mg/dl.), triglyceride (mg/dL), high-density lipoprotein cholesterol (HDL-c, mg/dL), low-density lipoprotein cholesterol (LDL-c, mg/dL), thyroid-stimulating hormone (TSH) (IU/mL), HbA1c level (%) and gastrin levels (pmol/L) were measured by using a sample of venous blood. TSH assays were performed via immunochemiluminescent assay (Architect c8200, Abbott). FBG, LDL-c, HDL-c, and triglyceride levels were measured by using the hexokinase 7/G-6-PDH method, a measured liquid-selective detergent method, an accelerator-selective detergent method, and a glycerol phosphate oxidase method (Architect c8200, Abbott), respectively. HbA1c was via the enzymatic method using Architect c4000 (Abbott) system from human complete blood and hemolysate. Serum gastrin level was measured by a competitive radioimmunoassay using a rabbit antiserum raised against a gastrin 17 albumin conjugate (DiaSource ImmunoAssasys S.A., Louvain-la-Neuve, Belgium). According to the manufacturer, the range of gastrin level is 11-54 pmol/L and the lowest detectable concentration is 5 pmol/L. All measurements were performed both at baseline and the follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esomeprazole 40mg Group | Active comparator | Drug: Esomeprazole 40mgIntervention group consisted of 16 diabetic subjects that had various degrees of symptoms for functional dyspepsia, gastro-oesophageal reflux, gastritis or duodenitis. All of them were prescribed 40 mg of esomeprazole treatment for three months. |
| Control Group | No intervention | –The control group consisted of without gastric complaints, thus who did not receive PPI drugs. This group was followed-up without any intervention for three months. |
Who may qualify
- Ages
- 47 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All the participants that has a diagnosis of T2DM and had at least 1-year follow-up in Endocrinology outpatient clinic.
- All the study participants were chosen from regulated diabetic subjects whose diabetes treatment were not amended.
- In the intervention group, all participants had various degrees of symptoms for functional dyspepsia, gastro-oesophageal reflux, gastritis or duodenitis
- The control group consisted of without gastric complaints, thus who did not receive PPI drugs.
Key exclusion criteria (5 listed)
- We excluded any cases needing revision in their treatment strategies due to ethical issues.
- Subjects, on pioglitazone and incretin-based therapies;
- Subjects with a history of gastrointestinal surgery, liver or kidney disease, diabetic macro- or microvascular complications;
- Subjects who are lactating or pregnant
- Subjects on any PPI treatment or had a history of PPI use in a 3 months period before the study, were excluded.
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 |
|---|---|---|
| Esomeprazole 40mgAlso: Nexium 40 mgEsomeprazole 40mg oral tablet, once a day | Drug | Esomeprazole 40mg Group |
Primary outcome
HbA1c change
Time frame: 3 months
HbA1c change with esomeprazole in 3 months
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 26 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Yusuf Bozkuş, Assist Prof study director
Başkent University Endocrinolgy Dep
Neslihan Başçıl Tütüncü, Prof principal investigator
Başkent University Endocrinolgy Dep
Özlem Turhan İyidir, Assoc Prof principal investigator
Başkent University Endocrinolgy Dep
Questions about this trial
What is this clinical trial studying?
A study testing Esomeprazole 40mg in people with Diabetes Mellitus, Type 2, run by Baskent University Ankara Hospital.
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 4 inclusion and 5 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
HbA1c change (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2018.