Type 2 DiabetesNCT02235194
Effects of an Amino Acid and Chromium-picolinate Containing Drink on Glucose Metabolism
A study testing Amino Acid and chromium-picolinate containing drink in people with Type 2 Diabetes and Prediabetes, run by Stoffwechselzentrum Rhein - Pfalz at 1 site in Germany.
Trial summary
It has previously been shown in healthy overweight subjects, that table water including a defined amount of amino acids and chromium can decrease the postprandial glucose and insulin response. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes, Prediabetes
- What is being tested?
- Amino Acid and chromium-picolinate containing drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2014to Nov 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Early Type 2 Diabetes (i.e. on Metformin or diet only)
- Prediabetes (i.e. FPG 100-125 mg/dl or IGT 2h PG in OGTT 140-199 mg/dl)
- HbA1c < 7%
- BMI 28,0-39,9 kg/m²
Who cannot join
- Any antidiabetic medication other than metformin
- Psychiatric Disease
- Acute Infections
- Alcohol or drug abuse
- Malignant tumors or hematologic disorders
- Heart failure NYHA III-IV
Show all 10Show fewer
- Acute coronary syndrome
- Any macrovascular event within previous 3 months
- Chronic kidney disease > Stage 3
- Pregnancy or Lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of an Amino Acid and Chromium Containing Table Water on Glucose Response to a Test Meal in Type 2 Diabetes Patients in a Double Blind Cross - Over Design
It has previously been shown in healthy overweight subjects, that table water including a defined amount of amino acids and chromium can decrease the postprandial glucose and insulin response. In this study, the effect of this table water on glucose excursions after a test meal containing a defined amount of available carbohydrates, protein and fat will be studied in patients with early type 2 diabetes or prediabetes according to guidelines that are treated with dietary measures or metformin only. The study will be conducted in a cross -over design, double blinded and placebo controlled including 20 participants. The primary endpoint of the study is the incremental area under the curve for plasma glucose (iAUCgluc) within 180 minutes after ingestion of the meal.
- Conditions
- Type 2 Diabetes, Prediabetes
- Being tested
- Amino Acid and chromium-picolinate containing drink, Placebo Drink
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino Acid and chromium-picolinate containing drinkDietary supplement
Amino Acid and chromium - picolinate containg water ist taken with a test meal to study efects on glucose and insulin response.
Placebo DrinkDietary supplement
Placebo drink ist taken with a test meal to study efects on glucose and insulin response.
| Study group | Role | What they receive |
|---|---|---|
| Amino Acids, Chromium - Picolinate | Active comparator | Verum drink containing the dietary supplements is taken with a test meal. INsulin and glucose response is documented for 180 minutes. Receives: Dietary Supplement: Amino Acid and chromium-picolinate containing drink; Dietary Supplement: Placebo Drink |
| Placebo Drink | Placebo comparator | Placebo Drink containing aroma only is taken with a test meal. INsulin and glucose response is documented for 180 minutes. Receives: Dietary Supplement: Amino Acid and chromium-picolinate containing drink; Dietary Supplement: Placebo Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve for Glucose
Area under the curve for glucose will be measured within 180 minutes after a test meal. Blood samples will be drawan at 8 timepoints during 180 minutes after ingestion of the test meal (0', 15', 30', 60', 90', 120', 150', 180').
Measured: 0', 15', 30', 60', 90', 120', 150', 180' post test meal
Secondary outcomes (4)
AUC for insulin
Blood samples will be drawan at 8 timepoints during 180 minutes after ingestion of the test meal (0', 15', 30', 60', 90', 120', 150', 180').
Measured: 0', 15', 30', 60', 90', 120', 150', 180' post test meal
Markers of inflammation
Blood samples will be drawan at 8 timepoints during 180 minutes after ingestion of the test meal (0', 15', 30', 60', 90', 120', 150', 180'). At these timepoints markers of inflammation will be measured (i.e. hsCRP and others)
Measured: at 0', 15', 30', 60', 90', 120', 150', 180' post test meal
markers of lipid metabolism
Triglycerides, VLDL and other parameters of lipid metabolism are planned to be measured within 180 minutes after a test meal at 0', 15', 30', 60', 90', 120', 150', 180'.
Measured: 0', 15', 30', 60', 90', 120', 150', 180' post test meal
Gut peptide hormones
Area under the curve for GLP-1, ghrelin, glucagone and GIP are measured within 180 minutes after the test meal.
Measured: 0', 15', 30', 60', 90', 120', 150', 180' post test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stoffwechselzentrum Rhein - Pfalz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Per Humpert, Stoffwechselzentrum Rhein - Pfalz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235194
- Sponsor's protocol ID
- SWZRP-14-01
- Status last verified
- Sep 2019
- First submitted
- 28 Aug 2014
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of an Amino Acid and Chromium Containing Table Water on Glucose Response to a Test Meal in Type 2 Diabetes Patients in a Double Blind Cross - Over Design
- ClinicalTrials.gov ID
- NCT02235194
- Acronym / sponsor ID
- SWZRP-14-01
- Conditions
- Type 2 Diabetes, Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stoffwechselzentrum Rhein - PfalzUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 9 Sep 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.
It has previously been shown in healthy overweight subjects, that table water including a defined amount of amino acids and chromium can decrease the postprandial glucose and insulin response. In this study, the effect of this table water on glucose excursions after a test meal containing a defined amount of available carbohydrates, protein and fat will be studied in patients with early type 2 diabetes or prediabetes according to guidelines that are treated with dietary measures or metformin only. The study will be conducted in a cross -over design, double blinded and placebo controlled including 20 participants. The primary endpoint of the study is the incremental area under the curve for plasma glucose (iAUCgluc) within 180 minutes after ingestion of the meal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amino Acids, Chromium - Picolinate | Active comparator | Dietary Supplement: Amino Acid and chromium-picolinate containing drink, Dietary Supplement: Placebo DrinkVerum drink containing the dietary supplements is taken with a test meal. INsulin and glucose response is documented for 180 minutes. |
| Placebo Drink | Placebo comparator | Dietary Supplement: Amino Acid and chromium-picolinate containing drink, Dietary Supplement: Placebo DrinkPlacebo Drink containing aroma only is taken with a test meal. INsulin and glucose response is documented for 180 minutes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Early Type 2 Diabetes (i.e. on Metformin or diet only)
- Prediabetes (i.e. FPG 100-125 mg/dl or IGT 2h PG in OGTT 140-199 mg/dl)
- HbA1c < 7%
- BMI 28,0-39,9 kg/m²
Key exclusion criteria (10 listed)
- Any antidiabetic medication other than metformin
- Psychiatric Disease
- Acute Infections
- Alcohol or drug abuse
- Malignant tumors or hematologic disorders
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 |
|---|---|---|
| Amino Acid and chromium-picolinate containing drinkAmino Acid and chromium - picolinate containg water ist taken with a test meal to study efects on glucose and insulin response. | Dietary supplement | Amino Acids, Chromium - Picolinate, Placebo Drink |
| Placebo DrinkPlacebo drink ist taken with a test meal to study efects on glucose and insulin response. | Dietary supplement | Amino Acids, Chromium - Picolinate, Placebo Drink |
Primary outcome
Area under the curve for Glucose
Time frame: 0', 15', 30', 60', 90', 120', 150', 180' post test meal
Area under the curve for glucose will be measured within 180 minutes after a test meal. Blood samples will be drawan at 8 timepoints during 180 minutes after ingestion of the test meal (0', 15', 30', 60', 90', 120', 150', 180').
4 secondary outcomes
AUC for insulin
Time frame: 0', 15', 30', 60', 90', 120', 150', 180' post test meal
Markers of inflammation
Time frame: at 0', 15', 30', 60', 90', 120', 150', 180' post test meal
markers of lipid metabolism
Time frame: 0', 15', 30', 60', 90', 120', 150', 180' post test meal
Gut peptide hormones
Time frame: 0', 15', 30', 60', 90', 120', 150', 180' post test meal
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 24 Sep 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino Acid and chromium-picolinate containing drink in people with Type 2 Diabetes and Prediabetes, run by Stoffwechselzentrum Rhein - Pfalz 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 4 inclusion and 10 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 24 Sep 2019. 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?
Area under the curve for Glucose (time frame: 0', 15', 30', 60', 90', 120', 150', 180' post test meal). 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 24 Sep 2019.