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

December 21, 2007
April 9, 2013
January 2007
July 2008   (final data collection date for primary outcome measure)
Hemoglobin A1c [ Time Frame: 4 weeks for each participant ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00585897 on ClinicalTrials.gov Archive Site
Fasting glucose [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Discontinuation of Sugar Sweetened Beverages
Title: Effects of Discontinuation of Sugar Sweetened Beverages on Hemoglobin A1c, Fasting and Post Prandial Blood Glucose in Type 2 Diabetics

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Type 2 Diabetes
  • Obesity
Behavioral: discontinuation of sugar sweetened beverages
Individual sessions which utilize motivational interviewing to assist participants to eliminate sugar sweetened beverages from their diet.
Experimental: Behavioral counseling
Individual sessions which utilize motivational interviewing to assist participants to discontinue sugar sweetened beverages from their diet.
Intervention: Behavioral: discontinuation of sugar sweetened beverages

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00585897
Pro00010382
No
Duke University
Duke University
Not Provided
Principal Investigator: Bryan C. Batch, M.D. Duke University
Duke University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP