Diabetes Mellitus Type 2NCT00822367
Blood Sugar Response to Commercial Nutritional Supplements in Patients With Type 2 Diabetes
A study testing Glucerna; Ensure; SlimFast in people with Diabetes Mellitus Type 2, run by Walter Reed Army Medical Center.
Trial summary
The purpose of the study is to determine which of the commonly used meal supplements is the best product for patients with DM. This is important because meal supplements are becoming more popular as meal replacements in the United States. Peak blood sugar occurs about 2 hours later after a meal. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Glucerna; Ensure; SlimFast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Sep 2007
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18-75 years
- Type-2 diabetes mellitus for over 3 months
- A1c of 7.0 - 10.0% within the past 3 months
- Controlled with diet /exercise and/or on oral anti-diabetic agents which are non-insulin secretatgogues, i.e. Metformin and/or Pioglitazone
- Able to give informed consent
- Expected to be in the DC metropolitan for the duration of the study
- Fasting blood glucose between 70 and 250 mg/dl
Who cannot join
- Patients with type 2 diabetes mellitus treated with insulin secretagogues (sulfonylurea and non-sulfonylurea), pramlintide (Symlin), GLP-1 analogs (Byetta), insulin, or alpha-glycosidase inhibitors
- A1c under 7.0% or over 10.0%
- Fasting blood glucose < 70 or > 250 mg/d
- Gastrointestinal disorders affecting digestion and absorption of nutrients such as lactose intolerance, chronic diarrhea, pancreatic insufficiency.
- Clinical history of documented gastroperesis.
- Patients on hemodialysis or peritoneal dialysis
- Pregnancy
- Inability to read and/or speak English
About this study
Official title: Assessment of Glycemic Response to Commercial Nutritional Supplements in Patients With Type 2 Diabetes Mellitus
The purpose of the study is to determine which of the commonly used meal supplements is the best product for patients with DM. This is important because meal supplements are becoming more popular as meal replacements in the United States. Peak blood sugar occurs about 2 hours later after a meal. Therefore, the best product would be the one that produces a smallest rise in blood sugar.
Read the detailed description
The purpose of the study is to determine which of the commonly used commercial nutritional supplements are preferential for patients with Diabetes Mellitus (DM). We will compare the post-prandial blood glucose (BG) responses in response to 3 different nutritional supplements each containing 50 grams of carbohydrate in adult patients with type 2 diabetes mellitus and relate these responses to one of the two well-recognized indices of insulin sensitivity - HOMA-R and QUICKI.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Glucerna; Ensure; SlimFast
- 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.
Glucerna; Ensure; SlimFastDietary supplement
Also called Glucerna Weight Loss Shake;Ensure with Fiber;SlimFast Shake
Each participant will consume all three nutritional supplements randomly assigned by computer program to drink one of the three products in one week intervals. Each product will contain 50 grams of carbohydrate but differs in volume, fat, protein, and fiber composition. BG will be tested by finger sticks before (fasting) and at 15, 30, 60, 90, 120, 150 and 180 minutes after drinking the supplement. The participants will have 8 finger stick blood sugar measurements over about 3 hours on each of the 3 testing days.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional suplements | Experimental | Not described Receives: Dietary Supplement: Glucerna; Ensure; SlimFast |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the nutritional supplements glycemic response in patients with DM, defined as the maximum glucose excursion, area under the curve, and 2 and 3 hour BG levels fol
Measured: BG will be tested by finger sticks before (fasting) and at 15, 30, 60, 90, 120, 150 and 180 minutes after drinking the supplement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startMay 2006
- Primary completionAug 2007
- Study completionSep 2007
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Investigators
- Robert A Vigersky, COL. MC. MD., Study director, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822367
- Sponsor's protocol ID
- 06-10010
- Status last verified
- Jan 2009
- First submitted
- 13 Jan 2009
- Last updated
- 14 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Glycemic Response to Commercial Nutritional Supplements in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00822367
- Acronym / sponsor ID
- 06-10010
- Conditions
- Diabetes Mellitus Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Study start
- May 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 14 Jan 2009 (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 which of the commonly used meal supplements is the best product for patients with DM. This is important because meal supplements are becoming more popular as meal replacements in the United States. Peak blood sugar occurs about 2 hours later after a meal. Therefore, the best product would be the one that produces a smallest rise in blood sugar.
Detailed description
The purpose of the study is to determine which of the commonly used commercial nutritional supplements are preferential for patients with Diabetes Mellitus (DM). We will compare the post-prandial blood glucose (BG) responses in response to 3 different nutritional supplements each containing 50 grams of carbohydrate in adult patients with type 2 diabetes mellitus and relate these responses to one of the two well-recognized indices of insulin sensitivity - HOMA-R and QUICKI.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional suplements | Experimental | Dietary Supplement: Glucerna; Ensure; SlimFast |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ages 18-75 years
- Type-2 diabetes mellitus for over 3 months
- A1c of 7.0 - 10.0% within the past 3 months
- Controlled with diet /exercise and/or on oral anti-diabetic agents which are non-insulin secretatgogues, i.e. Metformin and/or Pioglitazone
- Able to give informed consent
Key exclusion criteria (8 listed)
- Patients with type 2 diabetes mellitus treated with insulin secretagogues (sulfonylurea and non-sulfonylurea), pramlintide (Symlin), GLP-1 analogs (Byetta), insulin, or alpha-glycosidase inhibitors
- A1c under 7.0% or over 10.0%
- Fasting blood glucose < 70 or > 250 mg/d
- Gastrointestinal disorders affecting digestion and absorption of nutrients such as lactose intolerance, chronic diarrhea, pancreatic insufficiency.
- Clinical history of documented gastroperesis.
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 |
|---|---|---|
| Glucerna; Ensure; SlimFastAlso: Glucerna Weight Loss Shake;Ensure with Fiber;SlimFast ShakeEach participant will consume all three nutritional supplements randomly assigned by computer program to drink one of the three products in one week intervals. Each product will contain 50 grams of carbohydrate but differs in volume, fat, protein, and fiber composition. BG will be tested by finger sticks before (fasting) and at 15, 30, 60, 90, 120, 150 and 180 minutes after drinking the supplement. The participants will have 8 finger stick blood sugar measurements over about 3 hours on each of the 3 testing days. | Dietary supplement | Nutritional suplements |
Primary outcome
To determine the nutritional supplements glycemic response in patients with DM, defined as the maximum glucose excursion, area under the curve, and 2 and 3 hour BG levels fol
Time frame: BG will be tested by finger sticks before (fasting) and at 15, 30, 60, 90, 120, 150 and 180 minutes after drinking the supplement.
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 14 Jan 2009.
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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.
Robert A Vigersky, COL. MC. MD. study director
Walter Reed Army Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Glucerna; Ensure; SlimFast in people with Diabetes Mellitus Type 2, run by Walter Reed Army Medical Center.
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 8 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 14 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
To determine the nutritional supplements glycemic response in patients with DM, defined as the maximum glucose excursion, area under the curve, and 2 and 3 hour BG levels fol (time frame: BG will be tested by finger sticks before (fasting) and at 15, 30, 60, 90, 120, 150 and 180 minutes after drinking the supplement.). 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 14 Jan 2009.