Diabetes Mellitus, Type 2Phase 1NCT00128089
Trial of New Dietary Treatment of Diabetes
A Phase 1 study testing Dietary treatment in people with Diabetes Mellitus, Type 2, run by Manassas Internal Medicine at 1 site in United States.
Trial summary
This is a preliminary trial of a new dietary approach to the treatment of obesity related type 2 diabetes. Study terminated December 19, 2005 for administrative reasons. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Dietary treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Dec 2005
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus, type 2
- Obesity
- Ability to attend office visits in Manassas, Virginia
Who cannot join
- Dementia
- Institutionalized living
- Retinopathy, neuropathy
- Pregnancy
- Serious health problems such as heart disease or stroke
Trial locations and contacts
1 site in 1 country.
United States1 site
Manassas Internal Medicine
Manassas, Virginia, 20110
About this study
Official title: Phase 1 Trial of A New Dietary Treatment of Obesity Related Type 2 Diabetes
This is a preliminary trial of a new dietary approach to the treatment of obesity related type 2 diabetes.
Study terminated December 19, 2005 for administrative reasons.
Read the detailed description
Traditional dietary treatment of type 2 diabetes is complicated and often fails.
This is a dietary treatment that uses fingerstick testing of blood sugars and a remarkably simple algorithm to promptly lower the blood glucose to treatment goals.
A series of 10 overweight type 2 diabetic patients not well controlled, or needing medication for control, will be recruited to follow this plan; followup is to be until 6 months after the last patient is enrolled, or when all patients have normal A1Cs with no medication, whichever comes first.
Primary endpoints to be measured are A1C, weight loss (in pounds and BMI reduction) and medication reduction. Secondary endpoints are occurrences of hypoglycemia, reduction of medications for hypertension and hyperlipidemia, and patient satisfaction. As this is a Phase 1 trial, the only control group is historical controls (the patients themselves and the medical literature).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Dietary treatment
- Keywords
- Obesity, Dietary treatment, Fasting as medical therapy
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary treatmentBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin (A1C) changes
Weight (body mass index [BMI]) loss
Diabetes medication reduction
Secondary outcomes (3)
Hypoglycemia
Other medication reduction
Patient satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study startAug 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Manassas Internal Medicine
- Sponsor type
- University, hospital or other
- Investigators
- John F Cary, MD, Principal investigator, Manassas Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128089
- Sponsor's protocol ID
- 2005-1
- Status last verified
- Dec 2005
- First submitted
- 8 Aug 2005
- Last updated
- 21 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial of A New Dietary Treatment of Obesity Related Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00128089
- Acronym / sponsor ID
- 2005-1
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Obesity, Dietary treatment, Fasting as medical therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants
- Lead sponsor
- Manassas Internal MedicineUniversity, hospital or other
- Study start
- Aug 2005
- Study completion
- Dec 2005
- First posted
- 9 Aug 2005 (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.
This is a preliminary trial of a new dietary approach to the treatment of obesity related type 2 diabetes.
Study terminated December 19, 2005 for administrative reasons.
Detailed description
Traditional dietary treatment of type 2 diabetes is complicated and often fails.
This is a dietary treatment that uses fingerstick testing of blood sugars and a remarkably simple algorithm to promptly lower the blood glucose to treatment goals.
A series of 10 overweight type 2 diabetic patients not well controlled, or needing medication for control, will be recruited to follow this plan; followup is to be until 6 months after the last patient is enrolled, or when all patients have normal A1Cs with no medication, whichever comes first.
Primary endpoints to be measured are A1C, weight loss (in pounds and BMI reduction) and medication reduction. Secondary endpoints are occurrences of hypoglycemia, reduction of medications for hypertension and hyperlipidemia, and patient satisfaction. As this is a Phase 1 trial, the only control group is historical controls (the patients themselves and the medical literature).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diabetes mellitus, type 2
- Obesity
- Ability to attend office visits in Manassas, Virginia
Key exclusion criteria (5 listed)
- Dementia
- Institutionalized living
- Retinopathy, neuropathy
- Pregnancy
- Serious health problems such as heart disease or stroke
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 |
|---|---|---|
| Dietary treatment | Behavioural | – |
Primary outcome
Glycated hemoglobin (A1C) changes
Weight (body mass index [BMI]) loss
Diabetes medication reduction
3 secondary outcomes
Hypoglycemia
Other medication reduction
Patient satisfaction
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2005.
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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.
John F Cary, MD principal investigator
Manassas Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dietary treatment in people with Diabetes Mellitus, Type 2, run by Manassas Internal Medicine 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 5 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: stopped early, as of the sponsor's last update on 21 Dec 2005. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early. Results are not available in the source record.
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?
Glycated hemoglobin (A1C) changes. The study lists 3 primary outcomes in all. 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 21 Dec 2005.