Obese Type 2 Diabetic PatientsNCT00552890
Modified Atkins Diet and Type 2 Diabetic Patients
A study testing modified Atkins diet and ADA recommended diet in people with Obese Type 2 Diabetic Patients, run by Hadassah Medical Organization.
Trial summary
This randomized control trial compared the influence of an Atkins diet to that of the ADA recommended diet on Type 2 diabetic obese patients during a one-year follow-up period Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Obese Type 2 Diabetic Patients
- What is being tested?
- modified Atkins diet and ADA recommended diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Dec 2001to Feb 2004
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetic patients age 35-75 years
- BMI 30-39.9kg/m
- HbA1C>7%
- Not receiving insulin
- Micro-albumin excretion<60 mg/day
Who cannot join
- Serum creatinine level > 1.4 mg per deciliter
- Diastolic blood pressure > 100 mmHg or systolic blood pressure > 180mmHg
- Liver disease
- LDL cholesterol > 160 mg per deciliter despite lipid-lowering treatment
- Use of psychiatric medications
- Osteoporosis
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- Cancer
- Food allergies, and
- Low carbohydrate diet in the past 6 months.
About this study
Official title: Influende of a Modified Atkins Diet on Glucose Metabolism and Weight Loss in Obese Type 2 Diabetic Patients - A Randomized Controlled Trial
This randomized control trial compared the influence of an Atkins diet to that of the ADA recommended diet on Type 2 diabetic obese patients during a one-year follow-up period
- Conditions
- Obese Type 2 Diabetic Patients
- Being tested
- modified Atkins diet, ADA recommended diet
- Keywords
- obesity, atkins, weight reduction, kidney function
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified Atkins dietOther
subjects assigned to follow modified Atkins diet for 1 year
ADA recommended dietOther
subjects assigned to follow ADA recommended diet for period of 1 year
| Study group | Role | What they receive |
|---|---|---|
| ATK | Experimental | modified Atkins diet Receives: Other: modified Atkins diet |
| ADA | Experimental | subjects assigned to follow ADA recommended diet for 1 year Receives: Other: ADA recommended diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss and glucose control
Measured: 1 year
Secondary outcomes (1)
lipid profile, kidney function
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startDec 2001
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese Type 2 Diabetic PatientsStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Itamar Raz, MD, Principal investigator, Director, Diabetes Unit, Hadassah University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552890
- Sponsor's protocol ID
- atkins-hmo-ctil
- Status last verified
- Dec 2001
- First submitted
- 1 Nov 2007
- Last updated
- 2 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influende of a Modified Atkins Diet on Glucose Metabolism and Weight Loss in Obese Type 2 Diabetic Patients - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00552890
- Acronym / sponsor ID
- atkins-hmo-ctil
- Conditions
- Obese Type 2 Diabetic Patients
- Keywords
- obesity, atkins, weight reduction, kidney function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Dec 2001
- Study completion
- Feb 2004 (actual)
- First posted
- 2 Nov 2007 (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 randomized control trial compared the influence of an Atkins diet to that of the ADA recommended diet on Type 2 diabetic obese patients during a one-year follow-up period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATK | Experimental | Other: modified Atkins dietmodified Atkins diet |
| ADA | Experimental | Other: ADA recommended dietsubjects assigned to follow ADA recommended diet for 1 year |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetic patients age 35-75 years
- BMI 30-39.9kg/m
- HbA1C>7%
- Not receiving insulin
- Micro-albumin excretion<60 mg/day
Key exclusion criteria (9 listed)
- Serum creatinine level > 1.4 mg per deciliter
- Diastolic blood pressure > 100 mmHg or systolic blood pressure > 180mmHg
- Liver disease
- LDL cholesterol > 160 mg per deciliter despite lipid-lowering treatment
- Use of psychiatric 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 |
|---|---|---|
| modified Atkins dietsubjects assigned to follow modified Atkins diet for 1 year | Other | ATK |
| ADA recommended dietsubjects assigned to follow ADA recommended diet for period of 1 year | Other | ADA |
Primary outcome
weight loss and glucose control
Time frame: 1 year
1 secondary outcome
lipid profile, kidney function
Time frame: 1 year
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 2 Nov 2007.
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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.
Itamar Raz, MD principal investigator
Director, Diabetes Unit, Hadassah University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing modified Atkins diet and ADA recommended diet in people with Obese Type 2 Diabetic Patients, run by Hadassah Medical Organization.
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 5 inclusion and 9 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 2 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
weight loss and glucose control (time frame: 1 year). 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 2 Nov 2007.