DiabetesPhase 4DINENCT00599040
The DINE Study-Diet Intervention to Negate Diabetes Study (Improving Weight Loss Outcomes for African Americans)
A Phase 4 study testing The DASH diet with weight loss, The DASH diet without weight loss and Dairy diet in people with Diabetes and Hypertension, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to determine if what you eat affets your insulin sensitivity when you lose a small amount of weight Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Hypertension, Insulin Resistance
- What is being tested?
- The DASH diet with weight loss, The DASH diet without weight loss and Dairy diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Dec 2010
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American adults (age ≥ 19)
- Obese (BMI > or equal to 30 kg/m2)
- Otherwise generally healthy
Who cannot join
- Diagnoses of diabetes
- Malignancy or other states where weight loss is contraindicated (pregnancy
- Individuals with high blood pressure on medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham Nutrition Sciences Department
Birmingham, Alabama, 35294
About this study
The purpose of this study is to determine if what you eat affets your insulin sensitivity when you lose a small amount of weight
- Conditions
- Diabetes, Hypertension, Insulin Resistance
- Being tested
- The DASH diet with weight loss, The DASH diet without weight loss, Dairy diet
- Medical subject headings
- Diabetes Mellitus, Hypertension, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The DASH diet with weight lossBehavioural
A reduced calorie diet is provided to participants based on the DASH diet.
The DASH diet without weight lossBehavioural
participants are given a weight maintainenance diet based on the DASH diet
Dairy dietBehavioural
participants are given a high dairy, reduced calorie diet
| Study group | Role | What they receive |
|---|---|---|
| Weight loss | Active comparator | Weight loss diet focused on the DASH diet Receives: Behavioral: The DASH diet with weight loss |
| DASH diet | Active comparator | The DASH diet without weight loss Receives: Behavioral: The DASH diet without weight loss |
| Diary | Active comparator | Dairy Intervention Receives: Behavioral: Dairy diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startSep 2005
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Jamy Ard, MD, University of Alabama at Birmingham
- Investigators
- Jamy D Ard, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599040
- Sponsor's protocol ID
- F040719005
- Other IDs
- 1K23DK068223-01
- Acronym
- DINE
- Status last verified
- Mar 2013
- First submitted
- 10 Jan 2008
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DINE Study-Diet Intervention to Negate Diabetes Study (Improving Weight Loss Outcomes for African Americans)
- ClinicalTrials.gov ID
- NCT00599040
- Acronym / sponsor ID
- DINE / F040719005
- Conditions
- Diabetes, Hypertension, Insulin Resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 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.
The purpose of this study is to determine if what you eat affets your insulin sensitivity when you lose a small amount of weight
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Weight loss | Active comparator | Behavioral: The DASH diet with weight lossWeight loss diet focused on the DASH diet |
| DASH diet | Active comparator | Behavioral: The DASH diet without weight lossThe DASH diet without weight loss |
| Diary | Active comparator | Behavioral: Dairy dietDairy Intervention |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- African American adults (age ≥ 19)
- Obese (BMI > or equal to 30 kg/m2)
- Otherwise generally healthy
Key exclusion criteria (3 listed)
- Diagnoses of diabetes
- Malignancy or other states where weight loss is contraindicated (pregnancy
- Individuals with high blood pressure on medications.
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 |
|---|---|---|
| The DASH diet with weight lossA reduced calorie diet is provided to participants based on the DASH diet. | Behavioural | Weight loss |
| The DASH diet without weight lossparticipants are given a weight maintainenance diet based on the DASH diet | Behavioural | DASH diet |
| Dairy dietparticipants are given a high dairy, reduced calorie diet | Behavioural | Diary |
Primary outcome
Insulin Sensitivity
Time frame: 8 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 18 Mar 2013.
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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.
Jamy D Ard, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing The DASH diet with weight loss, The DASH diet without weight loss and Dairy diet in people with Diabetes and Hypertension, run by University of Alabama at Birmingham 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 3 inclusion and 3 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 18 Mar 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Insulin Sensitivity (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2013; AzTrials last refreshed its copy on 31 Oct 2026.