Diabetes Mellitus, Type 2NCT04016012
Overweight and Obesity in Relation to Type ll Diabetes Melitus
A study testing Local Zambian Foods in people with Diabetes Mellitus, Type 2 and Overweight and Obesity, run by Mukuba University at 1 site in Zambia.
Trial summary
The aim of the study is to evaluate the efficacy of local Zambian food in improving metabolic profiles of overweight/obese type ll diabetic patients in Kitwe district Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Overweight and Obesity
- What is being tested?
- Local Zambian Foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteZambia
- Study dates
- 30 Apr 2023to 15 Oct 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diabetic patients attending Kitwe Teaching Hospital
- 18 years and above
- Body Mass Index of 25 and above
- Willing to follow the diet plan and eat food provided
- Not enrolled in other clinical studies
Who cannot join
- Eating disorder or any psychosocial or scheduling factors that could impede study outcomes
- Have renal or liver problem
- Pregnant women
- Breast feeding women
- HIV positive individuals
Trial locations and contacts
1 site in 1 country.
Zambia1 site
Kitwe Teaching Hospital
Kitwe, Copperbelt, 50100
Given Chipili, +260978374900, chipiligiven@yahoo.com
About this study
Official title: Overweight and Obesity in Relation to Type II Melitus,Diabetes A Randomised Controlled Trial
The aim of the study is to evaluate the efficacy of local Zambian food in improving metabolic profiles of overweight/obese type ll diabetic patients in Kitwe district
- Conditions
- Diabetes Mellitus, Type 2, Overweight and Obesity
- Being tested
- Local Zambian Foods
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Zambian FoodsDietary supplement
Each week, participants in the intervention group will collect a pack of foodstuffs to last a week from the research site. The packs will be adjusted according to the weight of the participant and daily recommended allowances. Packaging of foodstuffs will be done in the food service lab at the Mukuba University. Instructions on how to prepare and use the food will be given to the participants. All food Items will be labelled diabetic food to avoid intra-household sharing.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Participants in the intervention group will receive local zambian foods and standard health care for eight (8) weeks. Receives: Dietary Supplement: Local Zambian Foods |
| Control arm | No intervention | The control group will have their usual (standard) diet in their home and receive standard health care for eight (8) weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood glucose levels
Fingertip blood sugar test using: blood glucose meter, test strips, lancet device, dry swabs, methylated spirit and a sharps box.
Measured: At baseline and 8 weeks
Secondary outcomes (2)
Change in Body weight
Weight will be measured using the Seca adult scale
Measured: At baseline and 8 weeks
Change of Body Mass Index (BMI)
Hand held BMI machine will be used to determine the BMI of each participant.
Measured: At baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start30 Apr 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion15 Oct 2023 (estimated)
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group will receive a diabetic controlled diet using local Zambian foods for 8 weeks and standard health care for 8 weeks while the control group will eat their usual food in their home and receive standard health care for eight (8) weeks.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mukuba University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zambia, Afe Babalola University, Nigeria, Buea University, Cameroon, Sokoine University of Agriculture, Kitwe Teaching Hospital, Zambia, National Science and Technology Council
- Responsible party
- Principal investigator, Given Chipili, Mukuba University
- Investigators
- Given Chipili, Principal investigator, Mukuba University, Kitwe, Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016012
- Sponsor's protocol ID
- MU0619
- Status last verified
- Sep 2022
- First submitted
- 7 Jul 2019
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected in this study will be published online
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overweight and Obesity in Relation to Type II Melitus,Diabetes A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04016012
- Acronym / sponsor ID
- MU0619
- Conditions
- Diabetes Mellitus, Type 2, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mukuba UniversityUniversity, hospital or other
- Collaborators
- University of Zambia, Afe Babalola University, Nigeria, Buea University, Cameroon, Sokoine University of Agriculture, Kitwe Teaching Hospital, Zambia, National Science and Technology Council
- Study start
- 30 Apr 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 11 Jul 2019 (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.
The aim of the study is to evaluate the efficacy of local Zambian food in improving metabolic profiles of overweight/obese type ll diabetic patients in Kitwe district
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention group will receive a diabetic controlled diet using local Zambian foods for 8 weeks and standard health care for 8 weeks while the control group will eat their usual food in their home and receive standard health care for eight (8) weeks.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Dietary Supplement: Local Zambian FoodsParticipants in the intervention group will receive local zambian foods and standard health care for eight (8) weeks. |
| Control arm | No intervention | –The control group will have their usual (standard) diet in their home and receive standard health care for eight (8) weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diabetic patients attending Kitwe Teaching Hospital
- 18 years and above
- Body Mass Index of 25 and above
- Willing to follow the diet plan and eat food provided
- Not enrolled in other clinical studies
Key exclusion criteria (5 listed)
- Eating disorder or any psychosocial or scheduling factors that could impede study outcomes
- Have renal or liver problem
- Pregnant women
- Breast feeding women
- HIV positive individuals
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 |
|---|---|---|
| Local Zambian FoodsEach week, participants in the intervention group will collect a pack of foodstuffs to last a week from the research site. The packs will be adjusted according to the weight of the participant and daily recommended allowances. Packaging of foodstuffs will be done in the food service lab at the Mukuba University. Instructions on how to prepare and use the food will be given to the participants. All food Items will be labelled diabetic food to avoid intra-household sharing. | Dietary supplement | Intervention arm |
Primary outcome
Change in Blood glucose levels
Time frame: At baseline and 8 weeks
Fingertip blood sugar test using: blood glucose meter, test strips, lancet device, dry swabs, methylated spirit and a sharps box.
2 secondary outcomes
Change in Body weight
Time frame: At baseline and 8 weeks
Change of Body Mass Index (BMI)
Time frame: At baseline and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: Yes. Data collected in this study will be published online
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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.
Given Chipili principal investigator
Mukuba University, Kitwe, Zambia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Zambian Foods in people with Diabetes Mellitus, Type 2 and Overweight and Obesity, run by Mukuba University at 1 site in Zambia.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Sep 2022. 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 Zambia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Given Chipili (+26097874900, chipiligiven@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood glucose levels (time frame: At baseline and 8 weeks). 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 21 Sep 2022.