Type 2 DiabetesNCT00585897
Effect of Discontinuation of Sugar Sweetened Beverages
A study testing discontinuation of sugar sweetened beverages in people with Type 2 Diabetes and Obesity, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- discontinuation of sugar sweetened beverages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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.
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: 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.
Read more
Specific aims to test hypothesis
- Investigate how elimination of sugar sweetened beverages from the diet affects HbA1c and plasma fasting and two hour post prandial blood glucose.
- Test the feasibility of carrying out a simple diet intervention in an outpatient population with type 2 diabetes.
Read the 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.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- discontinuation of sugar sweetened beverages
- Keywords
- Diabetes, Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
discontinuation of sugar sweetened beveragesBehavioural
Individual sessions which utilize motivational interviewing to assist participants to eliminate sugar sweetened beverages from their diet.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral counseling | Experimental | Individual sessions which utilize motivational interviewing to assist participants to discontinue sugar sweetened beverages from their diet. Receives: Behavioral: discontinuation of sugar sweetened beverages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Measured: 4 weeks for each participant
Secondary outcomes (1)
Fasting glucose
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startJan 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bryan C. Batch, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585897
- Sponsor's protocol ID
- Pro00010382
- Status last verified
- Dec 2012
- First submitted
- 21 Dec 2007
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15328331Schulze 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.
PubMed 15328324
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title: Effects of Discontinuation of Sugar Sweetened Beverages on Hemoglobin A1c, Fasting and Post Prandial Blood Glucose in Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT00585897
- Acronym / sponsor ID
- Pro00010382
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- Diabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 4 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Investigate how elimination of sugar sweetened beverages from the diet affects HbA1c and plasma fasting and two hour post prandial blood glucose.
- Test the feasibility of carrying out a simple diet intervention in an outpatient population with type 2 diabetes.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral counseling | Experimental | Behavioral: discontinuation of sugar sweetened beveragesIndividual sessions which utilize motivational interviewing to assist participants to discontinue sugar sweetened beverages from their diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Prior diagnosis of Type 2 Diabetes for at least 1 year based on one of the following:
- 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
Key exclusion criteria (6 listed)
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| discontinuation of sugar sweetened beveragesIndividual sessions which utilize motivational interviewing to assist participants to eliminate sugar sweetened beverages from their diet. | Behavioural | Behavioral counseling |
Primary outcome
Hemoglobin A1c
Time frame: 4 weeks for each participant
1 secondary outcome
Fasting glucose
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Background: PubMed 15328331Apovian 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.
- Background: PubMed 15328324Schulze 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan C. Batch, M.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing discontinuation of sugar sweetened beverages in people with Type 2 Diabetes and Obesity, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: 4 weeks for each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00585897, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.