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Pharmacist-led Therapeutic Nutritional Intervention in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03181165
Recruitment Status : Active, not recruiting
First Posted : June 8, 2017
Last Update Posted : December 20, 2019
Sponsor:
Collaborators:
Mitacs
Pharmasave
Information provided by (Responsible Party):
Jonathan Little, University of British Columbia

Brief Summary:
Type 2 diabetes represents a significant burden to both the individual and our healthcare system. Individuals with type 2 diabetes are typically prescribed one or more glucose-lowering medications, many of which have undesirable side effects (e.g., nausea, risk of cardiovascular complications, weight gain) and cost our healthcare system a lot of money. An alternative strategy to lower blood glucose is to consume a low-carbohydrate diet. However, adjusting medications after choosing to follow a low-carbohydrate diet can be difficult. Delivering a low-carbohydrate diet through pharmacists could circumvent this difficulty in medications adjustment because pharmacists are trained to adjust medications. In this study the investigators will determine whether type 2 diabetes patients can reduce medications and improve blood glucose by following a low-carbohydrate, low-calorie diet under the direction of a pharmacist.

Condition or disease Intervention/treatment Phase
Diet Modification Behavioral: Low-carbohydrate Therapeutic Nutrition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pragmatic effectiveness trial of diet intervention led by community pharmacists versus treatment-as-usual waitlist control.
Masking: None (Open Label)
Masking Description: Participants will know group assignments
Primary Purpose: Treatment
Official Title: Impact of a Pharmacist-led Therapeutic Nutritional Intervention on Medications and Glucose Control in Type 2 Diabetes
Actual Study Start Date : July 5, 2017
Actual Primary Completion Date : November 15, 2019
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low-carbohydrate Therapeutic Nutrition
A 12-week low-carbohydrate, energy-restricted diet will be administered using a combination of pre-packaged foods and whole foods from pre-specified lists.
Behavioral: Low-carbohydrate Therapeutic Nutrition
The pharmacist or pharmacy lifestyle coach will work with the participant to develop a diet plan that is low in carbohydrate and energy-restricted based on personal preferences and characteristics. A combination of pre-packaged low-carbohydrate foods and whole foods from pre-specified lists will be used.

No Intervention: Treatment-as-usual waitlist control
Participants will receive standard lifestyle advice to follow a low-fat, low-sugar, high fibre diet and aim to accumulate 150 minutes of moderate activity per week.



Primary Outcome Measures :
  1. Proportion of participants not on glucose-lowering medications [ Time Frame: 12 weeks ]
    Number of individuals taking no medications divided by the total number of participants.


Secondary Outcome Measures :
  1. Hemoglobin A1C [ Time Frame: 12 weeks ]
    Blood test to measure glucose control

  2. Reduction in glucose-lowering medications [ Time Frame: 12 weeks ]
    Reduction in total dose of glucose-lowering medications

  3. Body mass index [ Time Frame: 12 weeks ]
    Body mass in kilograms divided by height in meters squared.

  4. Waist circumference [ Time Frame: 12 weeks ]
    Waist circumference in centimeters

  5. Body fat percentage [ Time Frame: 12 weeks ]
    Body fat percentage measured by bioelectrical impedance analysis

  6. Body mass [ Time Frame: 12 weeks ]
    Body mass in kg

  7. Health related quality of life [ Time Frame: 12 weeks ]
    Short-form (SF)-20 questionnaire

  8. Reduction in non-glucose lowering medications [ Time Frame: 12 weeks ]
    Dose of medications other than glucose-lowering

  9. Blood lipid profile [ Time Frame: 12 weeks ]
    triglycerides, HDL and LDL cholesterol

  10. Fasting insulin [ Time Frame: 12 weeks ]
    Fasting insulin

  11. Fasting C-peptide [ Time Frame: 12 weeks ]
    fasting C-peptide

  12. C-reactive protein [ Time Frame: 12 weeks ]
    Fasting high-sensitivity C-reactive protein

  13. Liver enzymes [ Time Frame: 12 weeks ]
    liver alanine amino transferase, aspartate aminotransferase, gamma-gluatmyl transpeptidase

  14. Fasting plasma glucose [ Time Frame: 12 weeks ]
    Fasting plasma glucose

  15. Systolic Blood Pressure [ Time Frame: 12 weeks ]
    Systolic Blood Pressure measured by automatic cuff

  16. Diastolic Blood Pressure [ Time Frame: 12 weeks ]
    Diastolic Blood Pressure measured by automatic cuff


Other Outcome Measures:
  1. Habitual physical activity [ Time Frame: 12 weeks ]
    Godin leisure-time exercise questionnaire

  2. Energy intake [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
    3-day diet record

  3. Macronutrient intake [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
    3-day diet record

  4. Intervention Satisfaction [ Time Frame: 12 weeks ]
    Satisfaction with intervention delivery questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Between the ages of 30 and 75, have type 2 diabetes mellitus diagnosed by a physician, are taking one or more glucose-lowering medications, have a BMI ≥30, have no contraindications to following low-carbohydrate, energy-restricted, high-protein diet, and can read and speak English.

Exclusion Criteria:

Exlcusion criteria are:

  1. Recent (within the last 2 years) diagnosis of coronary heart disease, stroke, or a heart attack.
  2. Unstable cardiovascular disorder.
  3. History of liver disease.
  4. History of kidney disease or impaired renal function.
  5. Previously undergone bariatric surgery.
  6. Multiple sclerosis or other diagnosed neurological disease.
  7. Currently pregnant or lactating, or planning on becoming pregnant in the next 12 months.
  8. Any form of cancer within the last 5 years.
  9. Body mass index (BMI) of <30.
  10. Dietary restrictions that do not allow you to follow a low-carbohydrate, energy-restricted, high-protein diet (e.g., vegan, food allergies).
  11. Any sensitivities to the ingredients in the pre-packaged foods

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): NCT03181165


Locations
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Canada, British Columbia
University of British Columbia
Kelowna, British Columbia, Canada, V1V1V7
Sponsors and Collaborators
University of British Columbia
Mitacs
Pharmasave
Investigators
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Principal Investigator: Jonathan P Little, PhD University of British Columbia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jonathan Little, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03181165    
Other Study ID Numbers: H16-01539
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual values will be reported in figures if applicable.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan Little, University of British Columbia:
Low-carbohydrate
Low calorie
Energy restricted