Type 2 DiabetesNCT04319003
Pilot Sugar Reduction Intervention in Kiritimati Teenagers
A study testing Sugar-reduction intervention in people with Type 2 Diabetes and Obesity, run by University of Southern California at 2 sites in 2 countries.
Trial summary
Kiritimati is an isolated coral atoll in the Pacific Ocean, and is one of 32 islands that comprise the Republic of Kiribati. Obesity and type 2 diabetes rates are high in Kiribati, but the causes and rates of childhood obesity/diabetes are unknown. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- Sugar-reduction intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Aug 2018to 19 Sep 2018
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Enrolled in one of the two high schools on Kiritimati
Who cannot join
- > 18 years of age
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Southern California
Los Angeles, California, 90033
Kiribati1 site
Kiritimati
London
About this study
Official title: Surveillance of Obesity and Pre-Diabetes/Diabetes in Kiritimati School Children and Lifestyle Modifications to Reduce Risk
Kiritimati is an isolated coral atoll in the Pacific Ocean, and is one of 32 islands that comprise the Republic of Kiribati. Obesity and type 2 diabetes rates are high in Kiribati, but the causes and rates of childhood obesity/diabetes are unknown. However, it has been hypothesized that high consumption of sugar-sweetened beverages on Kiritimati may be a contributing factor. The investigators therefore conducted a study in Kiritimati in September 2018 with the aim of 1) quantifying obesity and diabetes rates amongst children on Kiritimati and 2) testing the feasibility of a sugar-reduction intervention in Kiritimati schools. The investigators randomized the two high schools on the island to either the control group or the intervention group. The investigators measured height/weight, continuous blood glucose (using flash glucose monitoring), and diet (using 24-hour diet recalls). One week into the study, the intervention school received an intervention, which consisted of installation of a water filter at the school, the provision of water bottles to each student at the school, and a 30-minute educational presentation on the link between sugar consumption and type 2 diabetes. The investigators then measured how blood glucose and diet changed the week following the intervention, and compared this to the control school.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- Sugar-reduction intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar-reduction interventionBehavioural
The intervention consisted of a) installation of a water filter at the school. b) each participant received a metal water bottle. c) a registered dietitian gave a 30-minute presentation on sugar reduction for the purposes of type 2 diabetes prevention
| Study group | Role | What they receive |
|---|---|---|
| Control School | No intervention | This school did not receive intervention (until after the study was completed) |
| Intervention School | Experimental | This school received a one-week sugar-reduction intervention Receives: Behavioral: Sugar-reduction intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean blood glucose (mg/dL)
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks. Mean blood glucose was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in mean amplitude of glycemic variability (MAGE) (mg/dL)
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks. Glycemic variability (mean amplitude of glycemic excursions) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in standard deviation (mg/dL) of continuous glucose monitor data
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks. Glycemic variability (standard deviation) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in coefficient of variation (percent) of continuous glucose monitor data
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks. Glycemic variability (coefficient of variation (percent) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in J-index of continuous glucose monitor data
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks. Glycemic variability (J-index) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in area under the curve of continuous glucose monitor data
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks. Glycemic variability (area under the curve) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in total sugar consumption (g/day) using 24-hour dietary recalls
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in total sugar intake between the control and intervention schools (time x group interaction).
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in added sugar consumption (g/day) using 24-hour dietary recalls
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in added sugar intake between the control and intervention schools (time x group interaction).
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in total water consumption (g/day) using 24-hour dietary recalls
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in total water intake between the control and intervention schools (time x group interaction).
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in unsweetened water consumption (servings/day) using 24-hour dietary recalls
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in unsweetened water intake between the control and intervention schools (time x group interaction).
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in energy (kcal/day) consumption using 24-hour dietary recalls
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in energy (kcal) intake between the control and intervention schools (time x group interaction).
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in total carbohydrate (g/day) consumption using 24-hour dietary recalls
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in total carbohydrate intake between the control and intervention schools (time x group interaction).
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in percent calories from carbohydrate consumption using 24-hour dietary recalls
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in % calories from carbohydrate intake between the control and intervention schools (time x group interaction).
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in percent calories from total sugars consumption using 24-hour dietary recalls
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in % calories from total sugars intake between the control and intervention schools (time x group interaction).
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in percent calories from added sugars consumption using 24-hour dietary recalls
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in % calories from added sugars intake between the control and intervention schools (time x group interaction).
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in sugary beverage (tioka) consumption using beverage frequency questionnaires
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in sugary beverage (tang) consumption using beverage frequency questionnaires
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in sugary beverage (toddy) consumption using beverage frequency questionnaires
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in sugary beverage (ice block) consumption using beverage frequency questionnaires
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in sugary beverage (soda) consumption using beverage frequency questionnaires
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in sugary beverage (juice) consumption using beverage frequency questionnaires
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in sugary beverage (fruit drinks) consumption using beverage frequency questionnaires
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Change in sugary beverage (coffee/tea) consumption using beverage frequency questionnaires
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Measured: 2 weeks (1 week pre- and 1 week post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start3 Aug 2018
- Primary completion19 Sep 2018
- Study completion19 Sep 2018
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.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Beale, University of Southern California
- Investigators
- Elizabeth Beale, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319003
- Sponsor's protocol ID
- HS-18-00505
- Status last verified
- Mar 2020
- First submitted
- 26 Feb 2020
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance of Obesity and Pre-Diabetes/Diabetes in Kiritimati School Children and Lifestyle Modifications to Reduce Risk
- ClinicalTrials.gov ID
- NCT04319003
- Acronym / sponsor ID
- HS-18-00505
- Conditions
- Type 2 Diabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 19 Sep 2018 (actual)
- First posted
- 24 Mar 2020 (actual)
- 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.
Kiritimati is an isolated coral atoll in the Pacific Ocean, and is one of 32 islands that comprise the Republic of Kiribati. Obesity and type 2 diabetes rates are high in Kiribati, but the causes and rates of childhood obesity/diabetes are unknown. However, it has been hypothesized that high consumption of sugar-sweetened beverages on Kiritimati may be a contributing factor. The investigators therefore conducted a study in Kiritimati in September 2018 with the aim of 1) quantifying obesity and diabetes rates amongst children on Kiritimati and 2) testing the feasibility of a sugar-reduction intervention in Kiritimati schools. The investigators randomized the two high schools on the island to either the control group or the intervention group. The investigators measured height/weight, continuous blood glucose (using flash glucose monitoring), and diet (using 24-hour diet recalls). One week into the study, the intervention school received an intervention, which consisted of installation of a water filter at the school, the provision of water bottles to each student at the school, and a 30-minute educational presentation on the link between sugar consumption and type 2 diabetes. The investigators then measured how blood glucose and diet changed the week following the intervention, and compared this to the control school.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control School | No intervention | –This school did not receive intervention (until after the study was completed) |
| Intervention School | Experimental | Behavioral: Sugar-reduction interventionThis school received a one-week sugar-reduction intervention |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Enrolled in one of the two high schools on Kiritimati
Key exclusion criteria (1 listed)
- > 18 years of age
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 |
|---|---|---|
| Sugar-reduction interventionThe intervention consisted of a) installation of a water filter at the school. b) each participant received a metal water bottle. c) a registered dietitian gave a 30-minute presentation on sugar reduction for the purposes of type 2 diabetes prevention | Behavioural | Intervention School |
Primary outcome
Change in mean blood glucose (mg/dL)
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks. Mean blood glucose was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
Change in mean amplitude of glycemic variability (MAGE) (mg/dL)
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks. Glycemic variability (mean amplitude of glycemic excursions) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
Change in standard deviation (mg/dL) of continuous glucose monitor data
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks. Glycemic variability (standard deviation) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
Change in coefficient of variation (percent) of continuous glucose monitor data
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks. Glycemic variability (coefficient of variation (percent) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
Change in J-index of continuous glucose monitor data
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks. Glycemic variability (J-index) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
Change in area under the curve of continuous glucose monitor data
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks. Glycemic variability (area under the curve) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
Change in total sugar consumption (g/day) using 24-hour dietary recalls
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in total sugar intake between the control and intervention schools (time x group interaction).
Change in added sugar consumption (g/day) using 24-hour dietary recalls
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in added sugar intake between the control and intervention schools (time x group interaction).
Change in total water consumption (g/day) using 24-hour dietary recalls
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in total water intake between the control and intervention schools (time x group interaction).
Change in unsweetened water consumption (servings/day) using 24-hour dietary recalls
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in unsweetened water intake between the control and intervention schools (time x group interaction).
Change in energy (kcal/day) consumption using 24-hour dietary recalls
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in energy (kcal) intake between the control and intervention schools (time x group interaction).
Change in total carbohydrate (g/day) consumption using 24-hour dietary recalls
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in total carbohydrate intake between the control and intervention schools (time x group interaction).
Change in percent calories from carbohydrate consumption using 24-hour dietary recalls
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in % calories from carbohydrate intake between the control and intervention schools (time x group interaction).
Change in percent calories from total sugars consumption using 24-hour dietary recalls
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in % calories from total sugars intake between the control and intervention schools (time x group interaction).
Change in percent calories from added sugars consumption using 24-hour dietary recalls
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in % calories from added sugars intake between the control and intervention schools (time x group interaction).
Change in sugary beverage (tioka) consumption using beverage frequency questionnaires
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Change in sugary beverage (tang) consumption using beverage frequency questionnaires
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Change in sugary beverage (toddy) consumption using beverage frequency questionnaires
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Change in sugary beverage (ice block) consumption using beverage frequency questionnaires
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Change in sugary beverage (soda) consumption using beverage frequency questionnaires
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Change in sugary beverage (juice) consumption using beverage frequency questionnaires
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Change in sugary beverage (fruit drinks) consumption using beverage frequency questionnaires
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Change in sugary beverage (coffee/tea) consumption using beverage frequency questionnaires
Time frame: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
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 26 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
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
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Elizabeth Beale, MD principal investigator
University of Southern California
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar-reduction intervention in people with Type 2 Diabetes and Obesity, run by University of Southern California at 2 sites in 2 countries.
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 1 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 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Kiribati. 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?
Change in mean blood glucose (mg/dL) (time frame: 2 weeks (1 week pre- and 1 week post-intervention)). The study lists 23 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 26 Mar 2020.