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NCT Number: NCT03181165

Pharmacist-led Therapeutic Nutritional Intervention in Type 2 Diabetes

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.

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Key information

Conditions

Diet Modification

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia

Kelowna, British Columbia, V1V1V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

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

Treatment and study plan

Low-carbohydrate Therapeutic Nutrition

Behavioral

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Mitacs
  • Pharmasave

Registry information

Official study title

Impact of a Pharmacist-led Therapeutic Nutritional Intervention on Medications and Glucose Control in Type 2 Diabetes

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jun 8, 2017
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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