The Effect of Esomeprazole on Type 2 Diabetes

NCT03598738 | Completed

• 1 other identifier: KA12/242
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Esomeprazole; Gastrin; HbA1c; Glycaemic Regulation

Outcome Measures

Primary Outcomes (1)

• HbA1c change

  HbA1c change with esomeprazole in 3 months

  3 months

Study Arms (2)

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.

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.

Interventions

Esomeprazole 40mg DRUG

Esomeprazole 40mg oral tablet, once a day

Also known as: Nexium 40 mg

Esomeprazole 40mg Group

Eligibility Criteria

• Age: 47 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baskent University Ankara Hospital: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yusuf Bozkuş, Assist Prof

  Başkent University Endocrinolgy Dep

  STUDY DIRECTOR

• Neslihan Başçıl Tütüncü, Prof

  Başkent University Endocrinolgy Dep

  PRINCIPAL INVESTIGATOR

• Özlem Turhan İyidir, Assoc Prof

  Başkent University Endocrinolgy Dep

  PRINCIPAL INVESTIGATOR

• Umut Mousa, Dr

  Başkent University Endocrinolgy Dep

  PRINCIPAL INVESTIGATOR

• Nazlı Kırnap, Dr

  Başkent University Endocrinolgy Dep

  PRINCIPAL INVESTIGATOR

• Canan Çiçek Demir, Dr

  Başkent University Endocrinolgy Dep

  PRINCIPAL INVESTIGATOR

• Aslı Nar, Assoc Prof

  Başkent University Endocrinolgy Dep

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 26, 2018

Record last verified: 2018-07