HypoglycaemiaNCT02057848
Carbohydrates to Prevent Hypoglycaemia During Physical Activity in Patients With Type 1 Diabetes
A study testing low amount of carbohydrates, high amount of carbohydrates and Rapid-acting carbohydrates in people with Hypoglycaemia, run by Michael A. Nauck at 1 site in Germany.
Trial summary
Backgrounds/Aims: It was the aim to prospectively study the optimum regime of "preventive" carbohydrate administration for prevention of hypoglycaemic episodes during a standardized bout of physical activity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypoglycaemia
- What is being tested?
- low amount of carbohydrates, high amount of carbohydrates and Rapid-acting carbohydrates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Feb 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes mellitus, 18-75 years, BMI 18-35 kg/m², Diabetes duration > 1 year
Who cannot join
- General bad health status, Malignant diseases, Systemic glucocorticoid treatment, Coronary heart disease, Uncontrolled arterial hypertension, Acute infection diseases, Diseases of liver or kidney with significant organ malfunction, Abuse of alcohol or other drugs, Participation in another trial in the last 3 months
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized Trial Testing Different Regimens of Carbohydrate Administration to Prevent Hypoglycaemia During a Standardized Bout of Moderate Physical Activity in Patients With Type 1 Diabetes
Backgrounds/Aims: It was the aim to prospectively study the optimum regime of "preventive" carbohydrate administration for prevention of hypoglycaemic episodes during a standardized bout of physical activity.
Read the detailed description
Research design and methods: 24 patients with type 1 diabetes participated in one experiment without physical activity and in three experiments with a 4 km, 60 min hike starting at 2 p.m., either administering 2 x 10 g or 2 x 20 g carbohydrates (muesli bars) before starting and at 30 min (during the hike). Plasma glucose was determined with a laboratory method and additional carbohydrates needed to treat hypoglycaemia between 2 and 8 p.m. were recorded.
- Conditions
- Hypoglycaemia
- Being tested
- low amount of carbohydrates, high amount of carbohydrates, Rapid-acting carbohydrates
- Keywords
- carbohydrate, hypoglycemia
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low amount of carbohydratesOther
different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes
high amount of carbohydratesOther
different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes
Rapid-acting carbohydratesOther
different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes
| Study group | Role | What they receive |
|---|---|---|
| low amount of carbohydrates | Active comparator | 2 x 10 g carbohydrates (muesli bars) Receives: Other: low amount of carbohydrates |
| high amount of carbohydrates | Active comparator | 2 x 20 g carbohydrates (muesli bars) Receives: Other: high amount of carbohydrates |
| Rapid-acting carbohydrates | Other | 30 g rapidly absorbable carboh. + 20 g muesli bar Receives: Other: Rapid-acting carbohydrates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startJul 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycaemiaStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael A. Nauck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael A. Nauck, Diabeteszentrum Bad Lauterberg im Harz
- Investigators
- Michael A. Nauck, Prof. Dr., Principal investigator, Diabeteszentrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057848
- Sponsor's protocol ID
- DZBL-2014-1
- Other IDs
- 2014-000561-46, 2014
- Status last verified
- Feb 2014
- First submitted
- 5 Feb 2014
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial Testing Different Regimens of Carbohydrate Administration to Prevent Hypoglycaemia During a Standardized Bout of Moderate Physical Activity in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02057848
- Acronym / sponsor ID
- DZBL-2014-1
- Conditions
- Hypoglycaemia
- Keywords
- carbohydrate, hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Michael A. NauckUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 7 Feb 2014 (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.
Backgrounds/Aims: It was the aim to prospectively study the optimum regime of "preventive" carbohydrate administration for prevention of hypoglycaemic episodes during a standardized bout of physical activity.
Detailed description
Research design and methods: 24 patients with type 1 diabetes participated in one experiment without physical activity and in three experiments with a 4 km, 60 min hike starting at 2 p.m., either administering 2 x 10 g or 2 x 20 g carbohydrates (muesli bars) before starting and at 30 min (during the hike). Plasma glucose was determined with a laboratory method and additional carbohydrates needed to treat hypoglycaemia between 2 and 8 p.m. were recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low amount of carbohydrates | Active comparator | Other: low amount of carbohydrates2 x 10 g carbohydrates (muesli bars) |
| high amount of carbohydrates | Active comparator | Other: high amount of carbohydrates2 x 20 g carbohydrates (muesli bars) |
| Rapid-acting carbohydrates | Other | Other: Rapid-acting carbohydrates30 g rapidly absorbable carboh. + 20 g muesli bar |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 1 diabetes mellitus, 18-75 years, BMI 18-35 kg/m², Diabetes duration > 1 year
Key exclusion criteria (2 listed)
- General bad health status, Malignant diseases, Systemic glucocorticoid treatment, Coronary heart disease, Uncontrolled arterial hypertension, Acute infection diseases, Diseases of liver or kidney with significant organ malfunction, Abuse of alcohol or other drugs, Participation in another trial in the last 3 months
- -
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 amount of carbohydratesdifferent regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes | Other | low amount of carbohydrates |
| high amount of carbohydratesdifferent regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes | Other | high amount of carbohydrates |
| Rapid-acting carbohydratesdifferent regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes | Other | Rapid-acting carbohydrates |
Primary outcome
Plasma glucose
Time frame: 6 hours
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 7 Feb 2014.
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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.
Michael A. Nauck, Prof. Dr. principal investigator
Diabeteszentrum
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 amount of carbohydrates, high amount of carbohydrates and Rapid-acting carbohydrates in people with Hypoglycaemia, run by Michael A. Nauck 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 1 inclusion and 2 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 7 Feb 2014. 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. 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?
Plasma glucose (time frame: 6 hours). 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 7 Feb 2014.