Effect of Discontinuation of Sugar Sweetened Beverages

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00585897
First received: December 21, 2007
Last updated: April 9, 2013
Last verified: December 2012
  Purpose

Purpose The purpose of this study is to investigate the effects of discontinuation of sugar sweetened beverages on hemoglobin A1c (HbA1c) and plasma fasting and post-prandial blood glucose in a population with type 2 diabetes.

Hypothesis Elimination of sugar sweetened beverages from the diet for a 4 week period will lead to a decrease in HbA1c and plasma fasting and 2 hour post prandial blood glucose in a population with a history of type 2 diabetes and high consumption of sugar sweetened beverages.

Specific aims to test hypothesis

  1. Investigate how elimination of sugar sweetened beverages from the diet affects HbA1c and plasma fasting and two hour post prandial blood glucose.
  2. Test the feasibility of carrying out a simple diet intervention in an outpatient population with type 2 diabetes.

Condition Intervention
Type 2 Diabetes
Obesity
Behavioral: discontinuation of sugar sweetened beverages

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Title: Effects of Discontinuation of Sugar Sweetened Beverages on Hemoglobin A1c, Fasting and Post Prandial Blood Glucose in Type 2 Diabetics

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 4 weeks for each participant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting glucose [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: January 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral counseling
Individual sessions which utilize motivational interviewing to assist participants to discontinue sugar sweetened beverages from their diet.
Behavioral: discontinuation of sugar sweetened beverages
Individual sessions which utilize motivational interviewing to assist participants to eliminate sugar sweetened beverages from their diet.

Detailed Description:

Type and Design of Study This will be a pilot study including adult patients age >/= 18 diagnosed with Type 2 Diabetes who are patients at the Duke Outpatient Clinic (DOC) or patients in the general medicine or family practice clinics in Durham County. The intervention will be elimination of sugar sweetened beverages from the diet in a population of type 2 diabetic subjects for four weeks. Sugar sweetened beverages will be defined as any liquid beverage containing calories that can be attributed to natural or added sugar. This will not include beverages that contain mainly artificial sweeteners (e.g.: NutraSweet®, saccharin, Splenda®, or Equal®), plain milk, or water.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Prior diagnosis of Type 2 Diabetes for at least 1 year based on one of the following:

    • Fasting blood glucose >126 on two separate occasions
    • Random blood glucose >200 with symptoms
    • Abnormal 75 or 100 gram Oral Glucose Tolerance Test (OGTT) defined as: fasting blood glucose >100, 2hour post prandial blood sugar of >140
    • On medications for diabetes (oral or insulin)
  2. Age >/=18
  3. Stable but uncontrolled blood glucose (Hemoglobin A1C >7%, </= 12%)
  4. Ingestion of at least three eight ounce servings of sugar sweetened beverage daily.
  5. Stable solid diet and exercise pattern and agreement not to change these during the study
  6. Able and willing to maintain a complete diet diary for three days each week of the study (total of 12 days of recording)
  7. Able to attend regular study visits
  8. Able to give informed consent
  9. Working phone number in order to contact patient
  10. Able and willing to understand and comply with the intervention

Exclusion Criteria:

  1. Women who are known to be pregnant at enrollment based on a positive pregnancy test. Pregnancy test will be given to all female subjects of child bearing age prior to enrollment in the study. Pregnant women will be excluded on the basis that blood glucose data are significantly affected by the physiology of pregnancy. This exclusion is not based on any potential risk to the pregnant women or fetus.
  2. Individuals <18 years of age
  3. Diagnosis of Type 1 Diabetes
  4. Malabsorbtive syndrome of any type (will be determined based on medical history from patient and/or medical chart)
  5. On Acarbose prior to start of study
  6. On a weight loss diet within one month of enrollment
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585897

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Bryan C. Batch, M.D. Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00585897     History of Changes
Other Study ID Numbers: Pro00010382
Study First Received: December 21, 2007
Last Updated: April 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Diabetes
Obesity

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Obesity
Body Weight
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014