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

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ClinicalTrials.gov Identifier: NCT02324010
Recruitment Status : Completed
First Posted : December 24, 2014
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Karen Jones, Royal Adelaide Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastroparesis Diabetes Mellitus Drug: Sitagliptin Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Sitagliptin on Postprandial Glycaemia, Incretin Hormones and Blood Pressure in Type 2 Diabetes - Relationship to Gastric Emptying
Study Start Date : July 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sitaglipltin (100mg)
Active drug (sitagliptin)
Drug: Placebo
Inactive drug (Placebo)
Other Name: Sugar pill

Placebo Comparator: Placebo (sugar pill)
Inactive drug (placebo)
Drug: Sitagliptin
100mg mane for 2 days
Other Name: MK-0431-075, Januvia




Primary Outcome Measures :
  1. Gastric emptying [ Time Frame: 3 hours per gastric emptying study (i.e. 6 hours) ]
    Gastric retention (percent in the total stomach)


Secondary Outcome Measures :
  1. Glycaemia [ Time Frame: 4 hours during each gastric empty study (i.e. 8 hours) ]
    blood glucose (mmol/L) and plasma insulin (mU/L)

  2. Gastrointestinal hormone release [ Time Frame: 4 hours during each gastric empty study (i.e. 8 hours) ]
    GLP-1, GIP, C-peptide, 3-OMG

  3. Intragastric meal distribution [ Time Frame: 3 hours during each gastric empty study (i.e. 6 hours) ]
    percent retention in the proximal and distal stomach

  4. Blood pressure [ Time Frame: 4.5 hours during each gastric empty study (i.e. 9 hours) ]
    systolic and diastolic blood pressure (mmHg)

  5. Heart rate [ Time Frame: 4.5 hours during each gastric empty study (i.e. 9 hours) ]
    Heart rate (beats per minute)

  6. 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)

  7. Cardiac output [ Time Frame: 4 hours during each gastric empty study (i.e. 8 hours) ]
    Finapres (L)

  8. Stroke volume [ Time Frame: 4 hours during each gastric empty study (i.e. 8 hours) ]
    Finapres (mL)

  9. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324010


Locations
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Australia, South Australia
University of Adelaide, Discipline of Medicine, Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
Royal Adelaide Hospital
Investigators
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Principal Investigator: Karen L Jones, DAppSci, PhD University of Adelaide
Publications:
Woerle H, Lindenberger T, Linke R, Foley JE, Ligueros-Sayalan AA, ZhangY, He Y-L, BelingerC, Goeke B, Schirra J. A single dose of vidagliptin (VILDA) decelerates gastric emptying (GE) in patients with type 2 diabetes (T2DM). American Diabetes Association, 67th Scientific Sessions 500-p (abstract), 2007.
Information JsP: Merck Sharp & Dohme (Australia) Pty Ltd. South Granville, NSW, Australia, 2008.

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Responsible Party: Karen Jones, Professor, Royal Adelaide Hospital
ClinicalTrials.gov Identifier: NCT02324010    
Other Study ID Numbers: 140916
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017
Keywords provided by Karen Jones, Royal Adelaide Hospital:
gastric emptying
glycemia
appetite
incretin hormones
Additional relevant MeSH terms:
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Gastroparesis
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action