The Effect of Esomeprazole on Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

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.
    

Intervention name(s): Esomeprazole 40mg
Intervention type(s): Drug
Intervention description(s): Esomeprazole 40mg oral tablet, once a day
Other intervention name(s): Nexium 40 mg
Intervention MeSH terms: Esomeprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esomeprazole; Gastrin; HbA1c; Glycaemic Regulation