Diabetes Mellitus Type 2LCDNCT02498990
Low Calorie Diet and Diabetes
A study testing Low calorie diet followed by life style intervention in people with Diabetes Mellitus Type 2 and Dyslipidemia, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The primary hypothesis is to investigate whether a low calorie diet for 7 weeks followed by continuous lifestyle advice is an effective option to achieve an improvement in glucose control as measured by HbA1c after 52 and 104 weeks as compared to baseline values in obese type 2 diabetes patients on either tablet or… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 2, Dyslipidemia, Non-alcoholic Fatty Liver Disease
- What is being tested?
- Low calorie diet followed by life style intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2015to Aug 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women of age 18-65 years at screening.
- Diagnosis of type 2 diabetes mellitus.
- BMI > 30 kg/m2.
- HbA1c > 52 mmol/mol.
- Stable weight ± 5% for at least 12 weeks prior to screening.
- Informed consent must be obtained by each subject before enrollment in the study.
Who cannot join
- Pregnant or brest-feeding women or women who are planning to become pregnant or breast-feeding.
- Type 1 diabetes mellitus or secondary forms of diabetes including pancreatic injury, cushing syndrome etc.
- Clinically significant diabetic complications
- Clinically symptomatic gastrointestinal or hepatic disease.
- History of gastric bypass, antrectomy or small bowel disease.
- History of pancreatitis.
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- Myocardial infarction within the past six months.
- Symptomatic ischemic heart disease, heart failure or stroke.
- Atrial fibrillation.
- Patients on treatment with warfarin.
- Diagnosed and/or treated malignancy within the past 5 years.
- Any of the following laboratory abnormalities at screening:
- ALT and/or AST > 3 times the upper limit of the normal range.
- Serum creatinine levels > 130 µmol/l.
- Clinically significant TSH out of the normal range.
- Uric acid > 50% above normal level.
- History of alcohol or other substance abuse within the past 2 years.
- Psychiatric disease including eating disorder, bulimia nervosa, depression, anxiety, psychotic disease.
- Potentially unreliable patients and those judged by the investigator to be unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Metabol Control After Weight Reduction With Low Calorie Diet in Type 2 Diabetes
The primary hypothesis is to investigate whether a low calorie diet for 7 weeks followed by continuous lifestyle advice is an effective option to achieve an improvement in glucose control as measured by HbA1c after 52 and 104 weeks as compared to baseline values in obese type 2 diabetes patients on either tablet or insulin treatment. The secondary hypothesis is to investigate whether the weight reduction therapy also has significant impact on various anthropometric, clinical and metabolic parameters associated with obesity.
Read the detailed description
This is a prospective study on the impact of low calorie diet followed by a weight maintenance program on 12 and 24 month glucose control in a cohort of patients with obesity and diabetes mellitus. The study will consist of 3 phases:
- Screening period (up to 12 weeks).
- Low calorie diet weeks 1-9. Seven weeks of low-calorie diet including 800 kcal/day followed by 2 weeks of gradual introduction of normal diet of eventually 1500-2000 kcal/day, i.e. 600 kcal/day deficit, based on present body weight and sex. At entry of the LCD-period, all medication for diabetes mellitus, with the exception of metformin and insulin, will be removed. During the LCD-period, insulin treatment will gradually be reduced and, if possible, withdrawn. Patients will perform daily self-monitoring of fasting and post-prandial plasma glucose. At each visit, which will take place once a week, the patients will see a physician, a nurse and a dietician. The patients will be given specific advice to increase their physical activity. Patients will remain on medication for dyslipidemia. Blood pressure will be measured at each visit and in case of blood pressure < 110/70 mmHg and/or in case of symptoms associated with hypotension including dizziness, medication for hypertension will be reduced or removed.
- Weight-maintenance program weeks 10-52.
- Follow up visits at months 15, 18, 21 and 24.
- Being tested
- Low calorie diet followed by life style intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Dyslipidemias, Non-alcoholic Fatty Liver Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low calorie diet followed by life style interventionBehavioural
- Low calorie diet of 800 kcal/day for 7 weeks.
- Life style intervention for the remaining study period
| Study group | Role | What they receive |
|---|---|---|
| Weight reduction | Experimental | Not described Receives: Behavioral: Low calorie diet followed by life style intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in HbA1c (mmol/mol) at 12 and 24 months
Measured: 12 months and 24 months
Secondary outcomes (4)
Change from Baseline in BMI (kg/m2) at 7 weeks, 6,12, and 24 months
Measured: 7 weeks, 6, 12 and 24 months
Change from Baseline in Liver Fat (Controlled Attenuation Parameter, db/m) at 7 weeks, 6, 12 and 24 months
Liver Fat Measured by Fibroscan
Measured: 7 weeks, 6, 12 and 24 months
Change from Baseline in Cholesterol (mmo/l) and Triglycerides (mmol/l) at 7 weeks, 6, 12 and 24 months
Measured: 7 weeks, 6,12 and 24 months
Change from Baseline in 2-hour Glucose (mmol/l) and Insulin (mU/l) by Glucose tolerance test at 7 weeks, 6, 12 and 24 months
Glucose tolerance test: oral administration of 75 g Glucose
Measured: 7 weeks, 6,12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionFeb 2024 (estimated)
- Study completionAug 2025 (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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Hoffstedt, Karolinska University Hospital
- Investigators
- Johan Hoffstedt, MD, PhD, Principal investigator, Karilonska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498990
- Sponsor's protocol ID
- 2015/628-31
- Acronym
- LCD
- Status last verified
- Feb 2021
- First submitted
- 3 Jul 2015
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Metabol Control After Weight Reduction With Low Calorie Diet in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02498990
- Acronym / sponsor ID
- LCD / 2015/628-31
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 15 Jul 2015 (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 primary hypothesis is to investigate whether a low calorie diet for 7 weeks followed by continuous lifestyle advice is an effective option to achieve an improvement in glucose control as measured by HbA1c after 52 and 104 weeks as compared to baseline values in obese type 2 diabetes patients on either tablet or insulin treatment. The secondary hypothesis is to investigate whether the weight reduction therapy also has significant impact on various anthropometric, clinical and metabolic parameters associated with obesity.
Detailed description
This is a prospective study on the impact of low calorie diet followed by a weight maintenance program on 12 and 24 month glucose control in a cohort of patients with obesity and diabetes mellitus. The study will consist of 3 phases:
- Screening period (up to 12 weeks).
- Low calorie diet weeks 1-9. Seven weeks of low-calorie diet including 800 kcal/day followed by 2 weeks of gradual introduction of normal diet of eventually 1500-2000 kcal/day, i.e. 600 kcal/day deficit, based on present body weight and sex. At entry of the LCD-period, all medication for diabetes mellitus, with the exception of metformin and insulin, will be removed. During the LCD-period, insulin treatment will gradually be reduced and, if possible, withdrawn. Patients will perform daily self-monitoring of fasting and post-prandial plasma glucose. At each visit, which will take place once a week, the patients will see a physician, a nurse and a dietician. The patients will be given specific advice to increase their physical activity. Patients will remain on medication for dyslipidemia. Blood pressure will be measured at each visit and in case of blood pressure < 110/70 mmHg and/or in case of symptoms associated with hypotension including dizziness, medication for hypertension will be reduced or removed.
- Weight-maintenance program weeks 10-52.
- Follow up visits at months 15, 18, 21 and 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight reduction | Experimental | Behavioral: Low calorie diet followed by life style intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women of age 18-65 years at screening.
- Diagnosis of type 2 diabetes mellitus.
- BMI > 30 kg/m2.
- HbA1c > 52 mmol/mol.
- Stable weight ± 5% for at least 12 weeks prior to screening.
Key exclusion criteria (19 listed)
- Pregnant or brest-feeding women or women who are planning to become pregnant or breast-feeding.
- Type 1 diabetes mellitus or secondary forms of diabetes including pancreatic injury, cushing syndrome etc.
- Clinically significant diabetic complications
- Clinically symptomatic gastrointestinal or hepatic disease.
- History of gastric bypass, antrectomy or small bowel disease.
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 |
|---|---|---|
| Low calorie diet followed by life style intervention1. Low calorie diet of 800 kcal/day for 7 weeks. 2. Life style intervention for the remaining study period | Behavioural | Weight reduction |
Primary outcome
Change from Baseline in HbA1c (mmol/mol) at 12 and 24 months
Time frame: 12 months and 24 months
4 secondary outcomes
Change from Baseline in BMI (kg/m2) at 7 weeks, 6,12, and 24 months
Time frame: 7 weeks, 6, 12 and 24 months
Change from Baseline in Liver Fat (Controlled Attenuation Parameter, db/m) at 7 weeks, 6, 12 and 24 months
Time frame: 7 weeks, 6, 12 and 24 months
Change from Baseline in Cholesterol (mmo/l) and Triglycerides (mmol/l) at 7 weeks, 6, 12 and 24 months
Time frame: 7 weeks, 6,12 and 24 months
Change from Baseline in 2-hour Glucose (mmol/l) and Insulin (mU/l) by Glucose tolerance test at 7 weeks, 6, 12 and 24 months
Time frame: 7 weeks, 6,12, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
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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.
Johan Hoffstedt, MD, PhD principal investigator
Karilonska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low calorie diet followed by life style intervention in people with Diabetes Mellitus Type 2 and Dyslipidemia, run by Karolinska University Hospital at 1 site in Sweden.
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 6 inclusion and 19 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 18 Feb 2021. 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 Sweden. 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?
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?
Change from Baseline in HbA1c (mmol/mol) at 12 and 24 months (time frame: 12 months and 24 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 18 Feb 2021.