Management of metformin-induced gastrointestinal problems
| ISRCTN | ISRCTN40695995 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40695995 |
| Secondary identifying numbers | 49165218 |
- Submission date
- 22/06/2018
- Registration date
- 10/07/2018
- Last edited
- 16/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Metformin is a medicine used to treat type 2 diabetes that causes gastrointestinal (digestive) problems. The aim of this study is to find out whether the adverse effects of metformin can be treated with proton pump inhibitor drugs such as omeprazole and pantoprazole.
Who can participate?
Patients aged 26-85 with type 2 diabetes who are using metformin
What does the study involve?
This study consists of two phases. In the first phase patients with type 2 diabetes using metformin of different doses (500 mg, 850 mg and 100 mg) are randomly selected. Patients with symptoms of gastrointestinal problems are noted, along with dose, age, gender, frequency and way of taking metformin, all collected from the patient and their records. In the second phase of the study patients with gastrointestinal problems are divided into three groups. The first group receive omeprazole 40 mg, the second group receive pantoperazole 40 mg, and the third group receive non-drug treatment (i.e., take metformin during meal) for one month. Gastrointestinal symptoms are recorded before and after the treatment by interviewing the participants. Their blood sugar levels are also noted.
What are the possible benefits and risks of participating?
The benefit to patients is that their tolerance to metformin could be increased and their quality of life could be better. There are no possible risks to the patients.
Where is the study run from?
1. Allied Hospital
2. Faisalabad Diabetic Center
3. Diabetic Institute Pakistan
When is the study starting and how long is it expected to run for?
May 2017 to December 2017
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
1. Miss Madeeha Fatima
2. Miss Saleha Sadeeqa
Contact information
Public
Lahore College for Women University
Jail Road
Lahore
54000
Pakistan
Public
Lahore College for Women University
Jail Road
Lahore
54000
Pakistan
Study information
| Study design | The study consisted of two parts: in the first phase a cross-sectional research design was used and in the second phase an experimental research (interventional) design was used |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Management of metformin-induced gastrointestinal problems by pharmacological and non-pharmacological treatment |
| Study objectives | Metformin is a biguanide that causes gastrointestinal problems. To manage the adverse effects of metformin proton pump inhibitors were used to investigate the outcome on the adverse effects. |
| Ethics approval(s) | 1. Board of Studies (BOS) and Advance Study Research Board (ASRB), Lahore College for Women University (LCWU), 26/05/2017 2. Hospital ethics committee Punjab Medical College Faisalabad, 19/07/2017, ref: PMC/PHRC/ERC/2017/11 |
| Health condition(s) or problem(s) studied | Metformin gastrointestinal adverse effects |
| Intervention | The first phase is a quantitative study in which a cross sectional research design was used. In this study patients having type 2 diabetes using metformin of different doses (500 mg, 850 mg and 100 mg) were considered. Patients having symptoms of metformin induced gastrointestinal problems were noted. The gastrointestinal symptoms induced by metformin were linked with dose, age, gender, frequency and way of intake of metformin. Data was collected from the patients by visiting the outpatient departments of different government and private hospitals. In the second phase of the study an experimental design was used. In this phase patients having metformin induced gastrointestinal problems were divided into three groups (convenience sampling was used). Each group consisted of 20 participants. The participants were subjected to PPIs in order to see the effectiveness of proton pump inhibitors such as omeprazole and pantoprazole. The first group of participants were subjected to omeprazole 40 mg. Similarly the second group was subjected to pantoperazole 40 mg. In this phase the initial symptoms of the patient were recorded and then after intervention the level and severity of the symptoms was again checked by directly interviewing the participants on their follow-up and recorded. Their blood sugar levels were also noted. In this way the effectiveness of the medicine is checked. The third group of the patients were subjected to non-pharmacological treatment i.e. take metformin during meals and the outcomes are recorded. The total duration of treatment with PPIs of each patient was one month and after one month patients were followed up. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Omeprazole, pantoperazole, metformin |
| Primary outcome measure | GI symptoms measured by interview at baseline and 1 month |
| Secondary outcome measures | Blood sugar level measured at baseline and 1 month |
| Overall study start date | 01/05/2017 |
| Completion date | 30/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Total sample size 300. In the interventional phase of the study three groups were made, each group contained 20 patients. |
| Key inclusion criteria | 1. Male and female aged 26-85 years 2. Patients diagnosed with Type 2 diabetes 3. Patients using metformin |
| Key exclusion criteria | 1. Type 1 diabetes patients 2. Patients under 26 and older than 85 years 3. Patients who were not taking metformin 4. Patients on insulin therapy alone |
| Date of first enrolment | 01/06/2017 |
| Date of final enrolment | 30/11/2017 |
Locations
Countries of recruitment
- Pakistan
Study participating centres
-
Pakistan
-
Pakistan
-
Pakistan
Sponsor information
University/education
Jail Road
Lahore
54000
Pakistan
"ROR" |
https://ror.org/02bf6br77 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request after the publication of the results of the study upon request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 16/08/2022 | Yes | No |
Additional files
Editorial Notes
16/08/2022: The unpublished results were uploaded as an additional file.
