Effects of Sitagliptin on Gastric Emptying, Glycaemia and Blood Pressure in Type 2 Diabetes

July 5, 2017 updated by: Karen Jones, Royal Adelaide Hospital

Effects of Sitagliptin on Postprandial Glycaemia, Incretin Hormones and Blood Pressure in Type 2 Diabetes - Relationship to Gastric Emptying

The purpose of this study is to evaluate the acute effects of sitagliptin on postprandial glycemia, incretin hormones and blood pressure, and the relationship to gastric emptying, after a mashed potato meal in patients with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to (i) evaluate the acute effects of the dipeptidyl peptidase-4 (DPP-4) inhibitor, sitagliptin (100mg once daily for two days), on gastric emptying, postprandial plasma glucose, insulin, glucagon and 'incretin' hormones (ie. glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)), blood pressure and heart rate after a high carbohydrate meal, and (ii) to determine whether the magnitude of the effects of sitagliptin on postprandial glycaemia and blood pressure is related to the rate of gastric emptying, in patients with type 2 diabetes.

The rate of entry of carbohydrate into the small intestine is especially important in patients with diabetes mellitus. Sitagliptin is an orally administered inhibitor of dipeptidyl-peptidase-IV (DPP-IV), the enzyme responsible for the degradation of GLP-1. It is hypothesized that sitagliptin will increase the GLP-1 response to, and thereby slow gastric emptying and diminish the glycaemic and blood pressure response to, a carbohydrate-containing meal.

Twenty healthy subjects (male and female) will be studied. Each subject will be studied on two occasions following treatment for 2 days with sitagliptin (100mg once daily) or matching placebo in a randomized, double blind, crossover design. Measurements of gastric emptying, intragastric meal distribution, blood glucose concentrations, gut hormones, blood pressure, splanchnic flow and appetite will be measured for 4 hours following ingestion of a mashed potato meal.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • University of Adelaide, Discipline of Medicine, Royal Adelaide Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes (World Health Organisation (WHO) criteria), managed by diet or metformin alone
  • Body mass index (BMI) 20 - 40 kg/m2
  • Males and females (females of reproductive potential must be using an appropriate contraceptive method)
  • Glycated haemoglobin (HbA1c) ≤ 8.5%
  • Haemoglobin above the lower limit of the normal range (i.e. >135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (i.e. >10mcg/L)

Exclusion Criteria:

  • Subjects with gastrointestinal disease, significant upper or lower gastrointestinal symptoms, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
  • Other significant illness, including epilepsy, cardiovascular or respiratory disease.
  • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.
  • Impaired renal or liver function (as assessed by calculated creatinine clearance < 50 mL/min using the Cockroft-Gault equation (27) or abnormal liver function tests (> 2 times upper limit of normal range)).
  • Requirement for medication known to influence blood pressure and/or heart rate and/or gastrointestinal function, drugs with anticholinergic effects
  • Alcohol consumption > 20 g per day
  • Smoking > 10 cigarettes per day
  • Pregnancy or lactation.
  • Vegetarian
  • Allergy to sitagliptin or any other 'gliptin'.
  • Donation of blood within the previous 3 months
  • Participation in any other research studies within the previous 3 months
  • Exposure to ionising radiation for research purposes in the previous 12 months
  • Inability to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sitaglipltin (100mg)
Active drug (sitagliptin)
Drug: Placebo
Inactive drug (Placebo)
Other Names:
  • Sugar pill
PLACEBO_COMPARATOR: Placebo (sugar pill)
Inactive drug (placebo)
Drug: Sitagliptin
100mg mane for 2 days
Other Names:
  • MK-0431-075, Januvia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric emptying
Time Frame: 3 hours per gastric emptying study (i.e. 6 hours)
Gastric retention (percent in the total stomach)
3 hours per gastric emptying study (i.e. 6 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycaemia
Time Frame: 4 hours during each gastric empty study (i.e. 8 hours)
blood glucose (mmol/L) and plasma insulin (mU/L)
4 hours during each gastric empty study (i.e. 8 hours)
Gastrointestinal hormone release
Time Frame: 4 hours during each gastric empty study (i.e. 8 hours)
GLP-1, GIP, C-peptide, 3-OMG
4 hours during each gastric empty study (i.e. 8 hours)
Intragastric meal distribution
Time Frame: 3 hours during each gastric empty study (i.e. 6 hours)
percent retention in the proximal and distal stomach
3 hours during each gastric empty study (i.e. 6 hours)
Blood pressure
Time Frame: 4.5 hours during each gastric empty study (i.e. 9 hours)
systolic and diastolic blood pressure (mmHg)
4.5 hours during each gastric empty study (i.e. 9 hours)
Heart rate
Time Frame: 4.5 hours during each gastric empty study (i.e. 9 hours)
Heart rate (beats per minute)
4.5 hours during each gastric empty study (i.e. 9 hours)
Splanchnic blood flow
Time Frame: 4 hours during each gastric empty study (i.e. 8 hours)
Doppler ultrasound of superior mesenteric artery flow (ml/min)
4 hours during each gastric empty study (i.e. 8 hours)
Cardiac output
Time Frame: 4 hours during each gastric empty study (i.e. 8 hours)
Finapres (L)
4 hours during each gastric empty study (i.e. 8 hours)
Stroke volume
Time Frame: 4 hours during each gastric empty study (i.e. 8 hours)
Finapres (mL)
4 hours during each gastric empty study (i.e. 8 hours)
Appetite
Time Frame: 4 hours during each gastric empty study (i.e. 8 hours)
visual analogue questionnaire to assess hunger, fullness, desire to eat (mm)
4 hours during each gastric empty study (i.e. 8 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Adelaide Hospital

Investigators

  • Principal Investigator: Karen L Jones, DAppSci, PhD, University of Adelaide

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

December 18, 2014

First Posted (ESTIMATE)

December 24, 2014

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2017

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 140916

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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