Diabetes Mellitus, Type 2NCT01178723
The Effects of Breakfast Size on Hormonal Profile in Adults With Type 2 Diabetes Mellitus
A study testing breakfast size in people with Diabetes Mellitus, Type 2, run by Wolfson Medical Center at 2 sites in Israel.
Trial summary
Studies has found a connection between breakfast consumption and obesity and obesity-related complications, but only few studies examined the effect of breakfast size. The purpose of this study is to examine the effect of breakfast size on several parameters in adults with Type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- breakfast size
- How many people
- 48 participants
- Where
- 2 sitesIsrael
- Study dates
- Start not givento not given
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ages: 30-70
- Type 2 diabetics who are treated on a diet and / or pills
- Patients who receive a stable drug treatment (no change in the type/dosage of drugs during the three months preceding the research)
- Obese or overweight (35> BMI> 25)
- Patients who did not participate in another research for at least 30 days
- Patients who agree to sign a consent form and participate in research
- Patients with high compliance.
Who cannot join
- Patients under the age 30 or over 70
- Type 1 I diabetics
- Patients who are insulin dependent
- Type 2 diabetics who are treated with injections
- BMI less than 25 or BMI over 35
- Patients who had Bariatric surgery
Show all 11Show fewer
- Patients with food absorption disorders
- Active malignant disease
- Thyroid function disorder
- Active psychiatric illness
- Pregnancy / breastfeeding
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Diabetes Unit, Wolfson Medical Center
Holon, 58100
Diabetes Unit, Wolfson Medical Center
Holon, 58100
Julio Wainstein, M.D, 03-5028716, Vainstein@wolfson.health.gov.il
About this study
Studies has found a connection between breakfast consumption and obesity and obesity-related complications, but only few studies examined the effect of breakfast size.
The purpose of this study is to examine the effect of breakfast size on several parameters in adults with Type 2 diabetes mellitus.
Read the detailed description
The prevalence of obesity has rapidly increased during recent decades, while the prevalence of skipping breakfast has increased.
Several studies have reported inverse relationships between the consumption of breakfast and BMI and weight gain. A study that examined the effect of breakfast size, found that an increased percentage of daily energy consumed at breakfast was associated with relatively lower weight gain. Preliminary results of clinical research (unpublished) show a connection between a large breakfast and weight loss and increased feeling of satiety throughout the day.
The purpose of this study is to examine the effect of breakfast size on blood glucose balance, and its correlation with hormonal profile (including appetite hormones), adipokines and pro-inflammatory cytokines, weight and body composition and lipid profile in adults with type 2 diabetes.
The study will use a randomized-controlled, non-blinded, prospective design, including 48 participants with type 2 diabetes, who are not insulin dependent.
The research group will receive instructions to eat a large breakfast compared with the control group that will receive instructions to eat a small breakfast.
The estimated duration of the study is about three months.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- breakfast size
- Keywords
- breakfast size, blood glucose balance, hormonal profile, appetite hormones, adipokines, pro-inflammatory cytokines
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breakfast sizeDietary supplement
The research group will receive instructions to eat a large breakfast, Dividing the total daily calories recommended to the patient to: breakfast - 1/8 of the total daily calories , lunch - 1/3 of the total daily calories and supper- 1/3 of the total daily calories.
(the rest of the calories will be snacks between the meals) In contrast, the control group that will receive instructions to eat a small breakfast.
Dividing the total daily calories recommended to the patient to: breakfast - 1/3 of the total daily calories , lunch - 1/4 of the total daily calories and supper- 1/4 of the total daily calories (the rest of the calories will snacks between the meals).
The instructions will be adapted to each patient individually
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose balance
HBA1C, C-peptid, insulin, glucose, HOMA-IR, Glycomark
Measured: three months
Secondary outcomes (4)
anthropometric parameters
weight, height, body composition
Measured: three months
Adipokines and hormones
insulin, leptin, ghrelin, adiponectin, GLP-1, cortisol
Measured: three months
pro-inflammatory cytokines
TNF-α, IL-6, MCP-1, CRP
Measured: three months
lipid profile
triglycerides, cholesterol, LDL, HDL
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178723
- Sponsor's protocol ID
- TASMC10JW0080CTIL
- Status last verified
- Aug 2010
- First submitted
- 8 Aug 2010
- Last updated
- 10 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Breakfast Size on Hormonal Profile in Adults With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01178723
- Acronym / sponsor ID
- TASMC10JW0080CTIL
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- breakfast size, blood glucose balance, hormonal profile, appetite hormones, adipokines, pro-inflammatory cytokines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- First posted
- 10 Aug 2010 (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.
Studies has found a connection between breakfast consumption and obesity and obesity-related complications, but only few studies examined the effect of breakfast size.
The purpose of this study is to examine the effect of breakfast size on several parameters in adults with Type 2 diabetes mellitus.
Detailed description
The prevalence of obesity has rapidly increased during recent decades, while the prevalence of skipping breakfast has increased.
Several studies have reported inverse relationships between the consumption of breakfast and BMI and weight gain. A study that examined the effect of breakfast size, found that an increased percentage of daily energy consumed at breakfast was associated with relatively lower weight gain. Preliminary results of clinical research (unpublished) show a connection between a large breakfast and weight loss and increased feeling of satiety throughout the day.
The purpose of this study is to examine the effect of breakfast size on blood glucose balance, and its correlation with hormonal profile (including appetite hormones), adipokines and pro-inflammatory cytokines, weight and body composition and lipid profile in adults with type 2 diabetes.
The study will use a randomized-controlled, non-blinded, prospective design, including 48 participants with type 2 diabetes, who are not insulin dependent.
The research group will receive instructions to eat a large breakfast compared with the control group that will receive instructions to eat a small breakfast.
The estimated duration of the study is about three months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women ages: 30-70
- Type 2 diabetics who are treated on a diet and / or pills
- Patients who receive a stable drug treatment (no change in the type/dosage of drugs during the three months preceding the research)
- Obese or overweight (35> BMI> 25)
- Patients who did not participate in another research for at least 30 days
Key exclusion criteria (11 listed)
- Patients under the age 30 or over 70
- Type 1 I diabetics
- Patients who are insulin dependent
- Type 2 diabetics who are treated with injections
- BMI less than 25 or BMI over 35
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 |
|---|---|---|
| breakfast sizeThe research group will receive instructions to eat a large breakfast, Dividing the total daily calories recommended to the patient to: breakfast - 1/8 of the total daily calories , lunch - 1/3 of the total daily calories and supper- 1/3 of the total daily calories. (the rest of the calories will be snacks between the meals) In contrast, the control group that will receive instructions to eat a small breakfast. Dividing the total daily calories recommended to the patient to: breakfast - 1/3 of the total daily calories , lunch - 1/4 of the total daily calories and supper- 1/4 of the total daily calories (the rest of the calories will snacks between the meals). The instructions will be adapted to each patient individually | Dietary supplement | – |
Primary outcome
blood glucose balance
Time frame: three months
HBA1C, C-peptid, insulin, glucose, HOMA-IR, Glycomark
4 secondary outcomes
anthropometric parameters
Time frame: three months
Adipokines and hormones
Time frame: three months
pro-inflammatory cytokines
Time frame: three months
lipid profile
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2010.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breakfast size in people with Diabetes Mellitus, Type 2, run by Wolfson Medical Center at 2 sites in Israel.
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 10 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julio Wainstein, M.D (03-5028716, vainstein@wolfson.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood glucose balance (time frame: three months). 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 10 Aug 2010.