DiabetesNCT01241695
Safety, Acceptability and Efficacy of a Long-term Intervention With a Diabetes-specific Low-carbohydrate, High-mono-unsaturated Fatty Acid Containing Oral Nutritional Supplement on Glycaemic Control in Type 2 Diabetic Patients
A study testing Oral nutritional supplement, food for special medical purposes in people with Diabetes, run by Fresenius Kabi at 1 site in Germany.
Trial summary
The purpose of the study is to determine the safety, acceptability and the efficacy of a 12-week intervention with a diabetes-specific oral nutritional supplement on glycaemic control in type 2 diabetic patients with or at risk of malnutrition Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Oral nutritional supplement, food for special medical purposes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Dec 2011
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of type 2 diabetes according to the WHO diagnostic criteria for more than 6 months: Fasting plasma glucose (FPG) ≥ 126 mg/dl (7.0 mmol/l) or 2-h plasma glucose ≥ 200 mg/dl (11.1 mmol/l) during an OGTT (oral glucose tolerance test);
- HbA1c between 6.5-8.5 % (confirmed in the previous 3 months),
- capable of using oral nutritional supplementation,
- on stable and controlled anti-diabetic regime for at least 1 months,
- use of metformin and/or sulphonylureas as oral anti-diabetic medication,
- in need of nutritional support because of ≥5% involuntary weight loss in the last 3 months, ≥10% involuntary weight loss in the last 6 months, inadequate nutritional intake causing failure to meet nutritional requirements or at risk of developing malnutrition
Who cannot join
- diabetes type 1,
- participation in a clinical trial with an investigational product or regular use of disease-specific oral nutritional supplements within 4 weeks prior to study start
- patients requiring a fibre free diet,
- enteral tube feed or parenteral nutrition,
- concomitant therapy with systemic glucocorticoids, insulins or anti-diabetic medication other than metformin and sulphonylureas,
- known or suspected intolerance or allergy to any component of the investigational product(s),
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- any acute gastrointestinal disease within 2 weeks prior to study entry,
- gastrectomy, gastroparesis or other gastric emptying abnormalities,
- acute sever heart failure (NYHA class 4), liver insufficiency / failure (male: ALAT > 150 U/l; female: ALAT > 120 U/l) or renal failure requiring dialysis,
- cancer cachexia,
- galactosaemia, fructosaemia,
- suspicion of drug abuse, abuse of/addiction to alcohol,
- pregnant or breast feeding women, or fertile women refusing to use contraceptives,
- patients with untreated major psychiatric disorder,
- known HIV positive (safety reasons),
- patient unable to co-operate adequately
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine the safety, acceptability and the efficacy of a 12-week intervention with a diabetes-specific oral nutritional supplement on glycaemic control in type 2 diabetic patients with or at risk of malnutrition
- Conditions
- Diabetes
- Being tested
- Oral nutritional supplement, food for special medical purposes
- Keywords
- Oral nutritional supplement, diabetes mellitus type 2, glycaemic control, Oral nutritional supplement (Food for special medical purposes)
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nutritional supplement, food for special medical purposesDietary supplement
2 servings of 200 ml per day, treatment period: 12 weeks
Oral nutritional supplement, food for special medical purposesDietary supplement
2 servings of 200 ml per day, treatment period: 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Diben DRINK (200 ml) / a diabetes-specific oral nutritional supplement Receives: Dietary Supplement: Oral nutritional supplement, food for special medical purposes |
| Control | Placebo comparator | Fresubin(R) energy fibre DRINK / an isoenergetic standard oral nutritional supplement Receives: Dietary Supplement: Oral nutritional supplement, food for special medical purposes |
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial blood glucose (iAUC) (0-240 min)
Measured: day 1
postprandial blood glucose (iAUC) (0-240 min)
Measured: day 42
postprandial blood glucose (iAUC) (0-240 min)
Measured: day 84
Secondary outcomes (9)
postprandial peak blood glucose (0-240 min)
Measured: day 1, day 42, day 84
postprandial triglycerides (0-240 min)
Measured: day 1, day 42, day 84
total cholesterol, HDL-cholesterol, LDL-cholesterol
Measured: day 1, day 42, day 84
total protein, albumin, prealbumin
Measured: day 1, day 42, day 84
HbA1c, HOMA-IR index
Measured: day 1, day 42, day 84
c-peptide
Measured: day 1, day 84
gastrointestinal tolerance
Measured: week 1, week 6, week 12
palatability / taste test
by means of a sensorial questionnaire the patients will evaluate the overall liking, appearance, smell, taste, mouth feel et cetera of the study nutrition.
Measured: week 1, week 6, week 12
daily compliance
in a daily compliance questionnaire the patients record the amount of oral nutritional supplements consumed.
Measured: day 1-84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2011
- Study completionDec 2011
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.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Mayr, Dr., Principal investigator, Medical Practice, 78333 Stockach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241695
- Sponsor's protocol ID
- GCOS-002-CFS
- Status last verified
- Nov 2010
- First submitted
- 10 Nov 2010
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Acceptability and Efficacy of a Long-term Intervention With a Diabetes-specific Low-carbohydrate, High-mono-unsaturated Fatty Acid Containing Oral Nutritional Supplement on Glycaemic Control in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT01241695
- Acronym / sponsor ID
- GCOS-002-CFS
- Conditions
- Diabetes
- Keywords
- Oral nutritional supplement, diabetes mellitus type 2, glycaemic control, Oral nutritional supplement (Food for special medical purposes)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Nov 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.
The purpose of the study is to determine the safety, acceptability and the efficacy of a 12-week intervention with a diabetes-specific oral nutritional supplement on glycaemic control in type 2 diabetic patients with or at risk of malnutrition
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Dietary Supplement: Oral nutritional supplement, food for special medical purposesDiben DRINK (200 ml) / a diabetes-specific oral nutritional supplement |
| Control | Placebo comparator | Dietary Supplement: Oral nutritional supplement, food for special medical purposesFresubin(R) energy fibre DRINK / an isoenergetic standard oral nutritional supplement |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of type 2 diabetes according to the WHO diagnostic criteria for more than 6 months: Fasting plasma glucose (FPG) ≥ 126 mg/dl (7.0 mmol/l) or 2-h plasma glucose ≥ 200 mg/dl (11.1 mmol/l) during an OGTT (oral glucose tolerance test);
- HbA1c between 6.5-8.5 % (confirmed in the previous 3 months),
- capable of using oral nutritional supplementation,
- on stable and controlled anti-diabetic regime for at least 1 months,
- use of metformin and/or sulphonylureas as oral anti-diabetic medication,
Key exclusion criteria (16 listed)
- diabetes type 1,
- participation in a clinical trial with an investigational product or regular use of disease-specific oral nutritional supplements within 4 weeks prior to study start
- patients requiring a fibre free diet,
- enteral tube feed or parenteral nutrition,
- concomitant therapy with systemic glucocorticoids, insulins or anti-diabetic medication other than metformin and sulphonylureas,
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 |
|---|---|---|
| Oral nutritional supplement, food for special medical purposes2 servings of 200 ml per day, treatment period: 12 weeks | Dietary supplement | Test |
| Oral nutritional supplement, food for special medical purposes2 servings of 200 ml per day, treatment period: 12 weeks | Dietary supplement | Control |
Primary outcome
postprandial blood glucose (iAUC) (0-240 min)
Time frame: day 1
postprandial blood glucose (iAUC) (0-240 min)
Time frame: day 42
postprandial blood glucose (iAUC) (0-240 min)
Time frame: day 84
9 secondary outcomes
postprandial peak blood glucose (0-240 min)
Time frame: day 1, day 42, day 84
postprandial triglycerides (0-240 min)
Time frame: day 1, day 42, day 84
total cholesterol, HDL-cholesterol, LDL-cholesterol
Time frame: day 1, day 42, day 84
total protein, albumin, prealbumin
Time frame: day 1, day 42, day 84
HbA1c, HOMA-IR index
Time frame: day 1, day 42, day 84
c-peptide
Time frame: day 1, day 84
gastrointestinal tolerance
Time frame: week 1, week 6, week 12
palatability / taste test
Time frame: week 1, week 6, week 12
daily compliance
Time frame: day 1-84
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 Jul 2012.
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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.
Peter Mayr, Dr. principal investigator
Medical Practice, 78333 Stockach
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral nutritional supplement, food for special medical purposes in people with Diabetes, run by Fresenius Kabi at 1 site in Germany.
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 16 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 Jul 2012. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
postprandial blood glucose (iAUC) (0-240 min) (time frame: day 1). 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 2 Jul 2012.