Condition category
Not Applicable
Date applied
22/06/2018
Date assigned
10/07/2018
Last edited
03/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Miss Madeeha Fatima

ORCID ID

Contact details

Lahore College for Women University
Jail Road
Lahore
54000
Pakistan

Type

Public

Additional contact

Miss Saleha Sadeeqa

ORCID ID

Contact details

Lahore College for Women University
Jail Road
Lahore
54000
Pakistan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

49165218

Study information

Scientific title

Management of metformin-induced gastrointestinal problems by pharmacological and non-pharmacological treatment

Acronym

Study hypothesis

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

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

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

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 trial start date

01/05/2017

Overall trial end date

30/12/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male and female aged 26-85 years
2. Patients diagnosed with Type 2 diabetes
3. Patients using metformin

Participant type

Patient

Age group

Adult

Gender

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.

Participant 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

Recruitment start date

01/06/2017

Recruitment end date

30/11/2017

Locations

Countries of recruitment

Pakistan

Trial participating centre

Allied Hospital
Faisalabad
-
Pakistan

Trial participating centre

Faisalabad Diabetic Center
Faisalabad
-
Pakistan

Trial participating centre

Diabetic Institute Pakistan
Lahore
-
Pakistan

Sponsor information

Organisation

Lahore College for Women University

Sponsor details

Jail Road
Lahore
54000
Pakistan

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
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.

Intention to publish date

30/12/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes