NCT00585897

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

October 14, 2015

Status Verified

December 1, 2012

Enrollment Period

1.5 years

First QC Date

December 21, 2007

Last Update Submit

October 11, 2015

Conditions

Type 2 DiabetesObesity

Keywords

DiabetesObesity

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    4 weeks for each participant

Secondary Outcomes (1)

  • Fasting glucose

    4 weeks

Study Arms (1)

Behavioral counseling

EXPERIMENTAL

Individual sessions which utilize motivational interviewing to assist participants to discontinue sugar sweetened beverages from their diet.

Behavioral: discontinuation of sugar sweetened beverages

Interventions

discontinuation of sugar sweetened beveragesBEHAVIORAL

Individual sessions which utilize motivational interviewing to assist participants to eliminate sugar sweetened beverages from their diet.

Behavioral counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • Age \>/=18
  • Stable but uncontrolled blood glucose (Hemoglobin A1C \>7%, \</= 12%)
  • Ingestion of at least three eight ounce servings of sugar sweetened beverage daily.
  • Stable solid diet and exercise pattern and agreement not to change these during the study
  • Able and willing to maintain a complete diet diary for three days each week of the study (total of 12 days of recording)
  • Able to attend regular study visits
  • Able to give informed consent
  • Working phone number in order to contact patient
  • Able and willing to understand and comply with the intervention

You may not qualify if:

  • Individuals \<18 years of age
  • Diagnosis of Type 1 Diabetes
  • Malabsorbtive syndrome of any type (will be determined based on medical history from patient and/or medical chart)
  • On Acarbose prior to start of study
  • On a weight loss diet within one month of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

  • Apovian CM. Sugar-sweetened soft drinks, obesity, and type 2 diabetes. JAMA. 2004 Aug 25;292(8):978-9. doi: 10.1001/jama.292.8.978. No abstract available.

    PMID: 15328331BACKGROUND

  • Schulze MB, Manson JE, Ludwig DS, Colditz GA, Stampfer MJ, Willett WC, Hu FB. Sugar-sweetened beverages, weight gain, and incidence of type 2 diabetes in young and middle-aged women. JAMA. 2004 Aug 25;292(8):927-34. doi: 10.1001/jama.292.8.927.

    PMID: 15328324BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bryan C. Batch, M.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 4, 2008

Study Start

January 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

October 14, 2015

Record last verified: 2012-12

Locations

US(1)