Glucose Metabolism DisorderNCT02520258
Study of the Reversibility of Glucose Intolerance Caused by Chronic Aspartame Consumption
A study testing Oral glucose tolerance test (OGTT) and Diet soda containing aspartame only in people with Glucose Metabolism Disorder, run by Rockefeller University at 1 site in United States.
Trial summary
Experiments have shown that some artificial sweeteners like those in diet soda can cause changes in how the body responds to and uses sugar. These changes increase the chance of obesity, type 2 diabetes, and other metabolic diseases. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorder
- What is being tested?
- Oral glucose tolerance test (OGTT) and Diet soda containing aspartame only
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 25 Jun 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18 - 45
- Weight stable for at least 3 months prior to screening (< 5% weight change)
- BMI of 21 - 29
- Cohort 1 - Aspartame Consumers: Primary dietary sweetener is aspartame; consumes at least 36 ounces of diet soda in which aspartame is a primary ingredient (Diet Coke or Diet Dr Pepper) a day for at least 6 months duration prior to study enrollment (Primary dietary sweetener is aspartame" should be defined as: "840g per week sucrose equivalent from aspartame and less than 280 grams per week sucrose equivalent from all other sweeteners (non-caloric and caloric sweeteners). For reference, one 12oz soda is 40g sucrose equivalent, and one teaspoon (one packet) of artificial sweetener is 4g sucrose equivalent.)"
- Cohort 2 - Aspartame Naïve Participants: Consumes less than or equal to 2 cans of diet soda per week
- Screening Visit #2 OGTT Outcome:
Show all 12Show fewer
- 0-h plasma glucose < 110 mg/dl AND
- 2-h plasma glucose < 140 mg/dl
- Abnormal OGTT during the screening phase of the study (area under curve on the high end of distribution)
- Must be able to comply with a metabolic Prudent diet
- Willing to fast 10 hours before each OGTT and BodPod
- Current level of exercise (aerobic and/or resistance training) must be able to be sustained while an in-patient
Who cannot join
- Any evidence of US National Cholesterol Education Program Adult Treatment Panel III
- Clinical Identification of the Metabolic Syndrome (must have 3 or more of the following risk factors):
- Abdominal Obesity, given as a waist circumference:
- Men >102 cm (>40 in)
- Women > 88 cm (>35 in)
- Triglycerides >150 mg/dl
Show all 35Show fewer
- HDL Cholesterol:
- Men < 40 mg/dl
- Women <50 mg/dl
- Blood Pressure >130/ >85 mm Hg
- Fasting Glucose > 110 mg/dl
- Average systolic blood pressure (SBP) > 150 mmHg and / or diastolic blood pressure (DBP) > 90 mmHG (based on 3 BPs taken at screening visit #1),
- LDL-C > 240mg/dl
- Triglycerides > 400 mg/dl
- Evidence of a liver disorder (ALT > three fold of the ULN)
- Evidence of any renal disease
- Currently on a weight-loss diet
- Diabetes
- Self-reported history of thyroid dysfunction
- Sugar sweetened beverage consumption (> 84 ounces per week)
- Hemoglobin <13.0 g/dl for males and 12.0 g/dl for females
- Current, prior (within 2 months), or anticipated use of any of the following medications:
- antihyperlipidemic, hyperglycemic medications, Antineoplastics, Antiretrovirals, Selective Serotonin Reuptake Inhibitors, Diuretics, Antihypertensives, Anticonvulsants, Hormone therapy, Birth control
- Self-reported antibiotic use within the previous 3 months
- Currently pregnant or lactating
- History of cardiac disease
- Active illegal drug user (self-reported)
- History of GI surgery (gastric bypass, bariatric, Roux-en-Y, colon resection, etc.)
- Habitual ingestion of > 2 alcoholic beverages/day
- Ever diagnosed with an eating disorder (self-reported)
- Use of steroids or beta agonists (orally, intranasal or inhaled) within a week of any OGTT
- Positive Hepatitis Serology (Hep. B surface Antibody; Hep. B surface antigen; Hep. C surface antibody)
- HIV Positive
- Tobacco use within the past 3 months
- Any medical or social condition that, in the opinion of the Investigator, might pose additional risk to the participant or confound the results of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University
New York, New York, 10065
About this study
Experiments have shown that some artificial sweeteners like those in diet soda can cause changes in how the body responds to and uses sugar. These changes increase the chance of obesity, type 2 diabetes, and other metabolic diseases. In this study, the investigators plan to see if the most common artificial sweetener, aspartame (brand name Equal, NutraSweet), causes these changes. The investigators believe that if metabolic changes are observed in a person who consumes aspartame, then removing all aspartame from the diet might lead to a reversal of the changes and a normalization of test results.This would impact sweetener additives in our foods and thus decrease the incidence of obesity, diabetes, and the metabolic syndrome.
Read the detailed description
Experiments have shown that some artificial sweeteners like those in diet soda can cause changes in how the body responds to and uses sugar. These changes increase the chance of obesity, type 2 diabetes mellitus, and other metabolic diseases. In this study, the investigators plan to see if the most commonly used artificial sweetener, aspartame, affects the body's response to sugar. The investigators believe that if metabolic changes are observed in a person who consumes aspartame, then removing all aspartame from the diet might lead to a reversal of the changes and a normalization of test results.
The investigators plan to study two (2) cohorts of healthy volunteers: 1) Those who regularly drink at least three cans per day of diet soda that contains aspartame (Cohort 1, Aspartame Consumers) and 2) participants who consume less than or equal to two (2) cans of diet soda per week (Cohort 2, Aspartame Naïve Participants).
Phase I of the study, the investigators will ask participants questions about their usual diet, including how much diet soda they usually drink. Participants will be screened by a test called the oral glucose tolerance test, or OGTT. This test involves coming to the hospital to drink sugary syrup, then have blood sugar checked every thirty (30) minutes for five (5) hours. Before the test, participants must refrain from eating or drinking anything for ten (10) hours. If the OGTT shows a high value, then the participant in cohort 1 (Aspartame Consumers) who regularly drink 3 or more cans per day of diet soda will be approached about continuing into the second phase of the study. For the participants in cohort 2 (consume less than or equal to two (2) cans of diet soda per week; Aspartame Naïve Participants), this will be the end of their participation in the study.
Phase II of the study, blood tests, OGTT, stool samples, and weight and body fat measurements a few times a week will track any changes in the participants during the study. During the phase II five (5) week study, participants will receive all of their meals from the Rockefeller University Hospital and should not have any outside food or drinks. The diet used throughout this study phase (II) is the Prudent Metabolic Diet. Participants can leave the hospital and continue to work, but must come for all tests and to receive meals. During Week One, participants will eat only food provided by the hospital but will continue to drink three (3) cans of diet soda per day. In Weeks Two through Four, participants will continue to eat food given to them by the hospital and will not be allowed to consume any foods or drinks that contain aspartame. In Week Five, participants will continue on the hospital diet, but will again start drinking three (3) cans of diet soda per day.
- Conditions
- Glucose Metabolism Disorder
- Being tested
- Oral glucose tolerance test (OGTT), Diet soda containing aspartame only
- Keywords
- artificial sweeteners, obesity, diabetes, metabolic syndrome, aspartame
- Medical subject headings
- Glucose Metabolism Disorders, Obesity, Diabetes Mellitus, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance test (OGTT)Other
OGTT will be conducted following a ten (10) hour fast on Screening Visit 2 (Screening Visit 2 may be conducted between Day -42 to Day 1).
Diet soda containing aspartame onlyOther
7 days of 36 oz diet soda po daily (Week 1), followed by 21 days washout (Weeks 2-4), and 7 days rechallenge (Week 5); Prudent metabolic diet; Oral glucose tolerance test (OGTT) on days (+/-2) 3, 7, 10, 14, 21, 28, 31, 35
| Study group | Role | What they receive |
|---|---|---|
| Aspartame Consumers - Cohort 1 | Experimental | Experimental Group/Arm
Phase I - Questionnaires and fasting oral glucose tolerance test (OGTT).
Phase II - (If OGTT results are abnormal, participants will be invited to participate in Phase II) Five (5) week study phase with Prudent Metabolic Diet and Intervention of diet soda containing aspartame only; Week 1: Prudent Metabolic Diet and 36oz diet soda po daily, Week 2-4: Prudent Metabolic Diet and no diet soda, Week 5: Prudent Metabolic Diet and 36 oz diet soda po daily. Receives: Other: Oral glucose tolerance test (OGTT); Other: Diet soda containing aspartame only |
| Aspartame Naive Participants - Cohort 2 | Active comparator | Control Group/Arm
Phase I - Questionnaires and fasting oral glucose tolerance test (OGTT).
Phase II - Not applicable for this cohort. Receives: Other: Oral glucose tolerance test (OGTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interval changes in blood glucose
Phase II (cohort 1): Interval changes in blood glucose will be quantified from area under the curve calculated from oral glucose tolerance tests (OGTT)
Measured: Interval 1: days 1 to 7; interval 2: days 8 to 28; interval 3: days 29 to 35
Blood glucose
Phase I (both cohorts): Blood glucose will be quantified from incremental area under the curve calculated from averaged oral glucose tolerance tests (OGTT)
Measured: Screening Visit 2: conducted between day -42 up to Day 1.
Secondary outcomes (16)
Interval changes in Glucagon
Phase II (cohort 1): Interval changes in glucagon will be quantified from area under the curve calculated from oral glucose tolerance tests (OGTT)
Measured: Interval 1: days 1 to 7; interval 2: days 8 to 28; interval 3: days 29 to 35
Glucagon
Phase I (both cohorts): glucagon will be quantified from area under the curve calculated from averaged oral glucose tolerance tests (OGTT)
Measured: Screening Visit 2: conducted between day -42 up to Day 1.
Interval changes in Peptide Tyrosine Tyrosine (PYY)
Phase II (cohort 1): Interval changes in PYY will be quantified from area under the curve calculated from oral glucose tolerance tests (OGTT)
Measured: Interval 1: days 1 to 7; interval 2: days 8 to 28; interval 3: days 29 to 35
Peptide Tyrosine Tyrosine (PYY)
Phase I (both cohorts): PYY will be quantified from area under the curve calculated from averaged oral glucose tolerance tests (OGTT)
Measured: Screening Visit 2: conducted between day -42 up to Day 1.
Interval changes in Leptin
Phase II (cohort 1): Interval changes in Leptin will be quantified from area under the curve calculated from oral glucose tolerance tests (OGTT)
Measured: Interval 1: days 1 to 7; interval 2: days 8 to 28; interval 3: days 29 to 35
Leptin
Phase I (both cohorts): Leptin will be quantified from area under the curve calculated from averaged oral glucose tolerance tests (OGTT)
Measured: Screening Visit 2: conducted between day -42 up to Day 1.
Interval changes in Insulin
Phase II (cohort 1): Interval changes in Insulin will be quantified from area under the curve calculated from oral glucose tolerance tests (OGTT)
Measured: Interval 1: days 1 to 7; interval 2: days 8 to 28; interval 3: days 29 to 35
Insulin
Phase I (both cohorts): Insulin will be quantified from area under the curve calculated from averaged oral glucose tolerance tests (OGTT)
Measured: Screening Visit 2: conducted between day -42 up to Day 1.
Interval changes in Ghrelin
Phase II (cohort 1): Interval changes in Ghrelin will be quantified from area under the curve calculated from oral glucose tolerance tests (OGTT)
Measured: Interval 1: days 1 to 7; interval 2: days 8 to 28; interval 3: days 29 to 35
Ghrelin
Phase I (both cohorts): Ghrelin will be quantified from area under the curve calculated from averaged oral glucose tolerance tests (OGTT)
Measured: Screening Visit 2: conducted between day -42 up to Day 1.
Interval changes in Glucagon-like peptide-1 (GLP-1)
Phase II (cohort 1): Interval changes in GLP-1 will be quantified from area under the curve calculated from oral glucose tolerance tests (OGTT)
Measured: Interval 1: days 1 to 7; interval 2: days 8 to 28; interval 3: days 29 to 35
Glucagon-like peptide-1 (GLP-1)
Phase I (both cohorts): GLP-1 will be quantified from area under the curve calculated from averaged oral glucose tolerance tests (OGTT)
Measured: Screening Visit 2: conducted between day -42 up to Day 1.
Interval changes in Glucose-dependent insulin-releasing peptide (GIP)
Phase II (cohort 1): Interval changes in GIP will be quantified from area under the curve calculated from oral glucose tolerance tests (OGTT)
Measured: Interval 1: days 1 to 7; interval 2: days 8 to 28; interval 3: days 29 to 35
Glucose-dependent insulin-releasing peptide (GIP)
Phase I (both cohorts): GIP will be quantified from area under the curve calculated from averaged oral glucose tolerance tests (OGTT)
Measured: Screening Visit 2: conducted between day -42 up to Day 1.
Interval Changes in C-peptide
Phase II (cohort 1): Interval changes in C-peptide will be quantified from area under the curve calculated from oral glucose tolerance tests (OGTT)
Measured: Interval 1: days 1 to 7; interval 2: days 8 to 28; interval 3: days 29 to 35
C-peptide
Phase I (both cohorts): C-peptide will be quantified from area under the curve calculated from averaged oral glucose tolerance tests (OGTT)
Measured: Screening Visit 2: conducted between day -42 up to Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startAug 2015
- Primary completion25 Jun 2019
- Study completion25 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism DisorderStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Huber, Rockefeller University
- Investigators
- Thomas Huber, MD PhD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520258
- Sponsor's protocol ID
- THU-0887
- Status last verified
- Jun 2020
- First submitted
- 30 Jul 2015
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Reversibility of Glucose Intolerance Caused by Chronic Aspartame Consumption
- ClinicalTrials.gov ID
- NCT02520258
- Acronym / sponsor ID
- THU-0887
- Conditions
- Glucose Metabolism Disorder
- Keywords
- artificial sweeteners, obesity, diabetes, metabolic syndrome, aspartame
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 11 Aug 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.
Experiments have shown that some artificial sweeteners like those in diet soda can cause changes in how the body responds to and uses sugar. These changes increase the chance of obesity, type 2 diabetes, and other metabolic diseases. In this study, the investigators plan to see if the most common artificial sweetener, aspartame (brand name Equal, NutraSweet), causes these changes. The investigators believe that if metabolic changes are observed in a person who consumes aspartame, then removing all aspartame from the diet might lead to a reversal of the changes and a normalization of test results.This would impact sweetener additives in our foods and thus decrease the incidence of obesity, diabetes, and the metabolic syndrome.
Detailed description
Experiments have shown that some artificial sweeteners like those in diet soda can cause changes in how the body responds to and uses sugar. These changes increase the chance of obesity, type 2 diabetes mellitus, and other metabolic diseases. In this study, the investigators plan to see if the most commonly used artificial sweetener, aspartame, affects the body's response to sugar. The investigators believe that if metabolic changes are observed in a person who consumes aspartame, then removing all aspartame from the diet might lead to a reversal of the changes and a normalization of test results.
The investigators plan to study two (2) cohorts of healthy volunteers: 1) Those who regularly drink at least three cans per day of diet soda that contains aspartame (Cohort 1, Aspartame Consumers) and 2) participants who consume less than or equal to two (2) cans of diet soda per week (Cohort 2, Aspartame Naïve Participants).
Phase I of the study, the investigators will ask participants questions about their usual diet, including how much diet soda they usually drink. Participants will be screened by a test called the oral glucose tolerance test, or OGTT. This test involves coming to the hospital to drink sugary syrup, then have blood sugar checked every thirty (30) minutes for five (5) hours. Before the test, participants must refrain from eating or drinking anything for ten (10) hours. If the OGTT shows a high value, then the participant in cohort 1 (Aspartame Consumers) who regularly drink 3 or more cans per day of diet soda will be approached about continuing into the second phase of the study. For the participants in cohort 2 (consume less than or equal to two (2) cans of diet soda per week; Aspartame Naïve Participants), this will be the end of their participation in the study.
Phase II of the study, blood tests, OGTT, stool samples, and weight and body fat measurements a few times a week will track any changes in the participants during the study. During the phase II five (5) week study, participants will receive all of their meals from the Rockefeller University Hospital and should not have any outside food or drinks. The diet used throughout this study phase (II) is the Prudent Metabolic Diet. Participants can leave the hospital and continue to work, but must come for all tests and to receive meals. During Week One, participants will eat only food provided by the hospital but will continue to drink three (3) cans of diet soda per day. In Weeks Two through Four, participants will continue to eat food given to them by the hospital and will not be allowed to consume any foods or drinks that contain aspartame. In Week Five, participants will continue on the hospital diet, but will again start drinking three (3) cans of diet soda per day.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspartame Consumers - Cohort 1 | Experimental | Other: Oral glucose tolerance test (OGTT), Other: Diet soda containing aspartame onlyExperimental Group/Arm Phase I - Questionnaires and fasting oral glucose tolerance test (OGTT). Phase II - (If OGTT results are abnormal, participants will be invited to participate in Phase II) Five (5) week study phase with Prudent Metabolic Diet and Intervention of diet soda containing aspartame only; Week 1: Prudent Metabolic Diet and 36oz diet soda po daily, Week 2-4: Prudent Metabolic Diet and no diet soda, Week 5: Prudent Metabolic Diet and 36 oz diet soda po daily. |
| Aspartame Naive Participants - Cohort 2 | Active comparator | Other: Oral glucose tolerance test (OGTT)Control Group/Arm Phase I - Questionnaires and fasting oral glucose tolerance test (OGTT). Phase II - Not applicable for this cohort. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Male or female aged 18 - 45
- Weight stable for at least 3 months prior to screening (< 5% weight change)
- BMI of 21 - 29
- Cohort 1 - Aspartame Consumers: Primary dietary sweetener is aspartame; consumes at least 36 ounces of diet soda in which aspartame is a primary ingredient (Diet Coke or Diet Dr Pepper) a day for at least 6 months duration prior to study enrollment (Primary dietary sweetener is aspartame" should be defined as: "840g per week sucrose equivalent from aspartame and less than 280 grams per week sucrose equivalent from all other sweeteners (non-caloric and caloric sweeteners). For reference, one 12oz soda is 40g sucrose equivalent, and one teaspoon (one packet) of artificial sweetener is 4g sucrose equivalent.)"
- Cohort 2 - Aspartame Naïve Participants: Consumes less than or equal to 2 cans of diet soda per week
Key exclusion criteria (35 listed)
- Any evidence of US National Cholesterol Education Program Adult Treatment Panel III
- Clinical Identification of the Metabolic Syndrome (must have 3 or more of the following risk factors):
- Triglycerides >150 mg/dl
- Blood Pressure >130/ >85 mm Hg
- Fasting Glucose > 110 mg/dl
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 glucose tolerance test (OGTT)OGTT will be conducted following a ten (10) hour fast on Screening Visit 2 (Screening Visit 2 may be conducted between Day -42 to Day 1). | Other | Aspartame Consumers - Cohort 1, Aspartame Naive Participants - Cohort 2 |
| Diet soda containing aspartame only7 days of 36 oz diet soda po daily (Week 1), followed by 21 days washout (Weeks 2-4), and 7 days rechallenge (Week 5); Prudent metabolic diet; Oral glucose tolerance test (OGTT) on days (+/-2) 3, 7, 10, 14, 21, 28, 31, 35 | Other | Aspartame Consumers - Cohort 1 |
Primary outcome
Interval changes in blood glucose
Time frame: Interval 1: days 1 to 7; interval 2: days 8 to 28; interval 3: days 29 to 35
Phase II (cohort 1): Interval changes in blood glucose will be quantified from area under the curve calculated from oral glucose tolerance tests (OGTT)
Blood glucose
Time frame: Screening Visit 2: conducted between day -42 up to Day 1.
Phase I (both cohorts): Blood glucose will be quantified from incremental area under the curve calculated from averaged oral glucose tolerance tests (OGTT)
16 secondary outcomes
Interval changes in Glucagon
Time frame: Interval 1: days 1 to 7; interval 2: days 8 to 28; interval 3: days 29 to 35
Glucagon
Time frame: Screening Visit 2: conducted between day -42 up to Day 1.
Interval changes in Peptide Tyrosine Tyrosine (PYY)
Time frame: Interval 1: days 1 to 7; interval 2: days 8 to 28; interval 3: days 29 to 35
Peptide Tyrosine Tyrosine (PYY)
Time frame: Screening Visit 2: conducted between day -42 up to Day 1.
Interval changes in Leptin
Time frame: Interval 1: days 1 to 7; interval 2: days 8 to 28; interval 3: days 29 to 35
Leptin
Time frame: Screening Visit 2: conducted between day -42 up to Day 1.
Interval changes in Insulin
Time frame: Interval 1: days 1 to 7; interval 2: days 8 to 28; interval 3: days 29 to 35
Insulin
Time frame: Screening Visit 2: conducted between day -42 up to Day 1.
Interval changes in Ghrelin
Time frame: Interval 1: days 1 to 7; interval 2: days 8 to 28; interval 3: days 29 to 35
Ghrelin
Time frame: Screening Visit 2: conducted between day -42 up to Day 1.
Interval changes in Glucagon-like peptide-1 (GLP-1)
Time frame: Interval 1: days 1 to 7; interval 2: days 8 to 28; interval 3: days 29 to 35
Glucagon-like peptide-1 (GLP-1)
Time frame: Screening Visit 2: conducted between day -42 up to Day 1.
Interval changes in Glucose-dependent insulin-releasing peptide (GIP)
Time frame: Interval 1: days 1 to 7; interval 2: days 8 to 28; interval 3: days 29 to 35
Glucose-dependent insulin-releasing peptide (GIP)
Time frame: Screening Visit 2: conducted between day -42 up to Day 1.
Interval Changes in C-peptide
Time frame: Interval 1: days 1 to 7; interval 2: days 8 to 28; interval 3: days 29 to 35
C-peptide
Time frame: Screening Visit 2: conducted between day -42 up to Day 1.
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 4 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Glucose Metabolism Disorder
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
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.
Thomas Huber, MD PhD principal investigator
Rockefeller University
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 glucose tolerance test (OGTT) and Diet soda containing aspartame only in people with Glucose Metabolism Disorder, run by Rockefeller University at 1 site in United States.
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 12 inclusion and 35 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 4 Jun 2020. 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 United States. 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?
Interval changes in blood glucose (time frame: Interval 1: days 1 to 7; interval 2: days 8 to 28; interval 3: days 29 to 35). The study lists 2 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 4 Jun 2020.