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NCT04016012 Clinical Trial

Overweight and Obesity in Relation to Type ll Diabetes Melitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Overweight and Obesity in Relation to Type II Melitus,Diabetes A Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04016012
Other study ID # MU0619
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 30, 2023
Est. completion date October 15, 2023

Study information
Verified date September 2022
Source Mukuba University
Contact Given Chipili
Phone +26097874900
Email chipiligiven@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 90
Est. completion date October 15, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Local Zambian Foods
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.

Locations
Country Name City State
Zambia Kitwe Teaching Hospital Kitwe Copperbelt

Sponsors (7)
Lead Sponsor Collaborator
Mukuba University Afe Babalola University, Nigeria, Buea University, Cameroon, Kitwe Teaching Hospital, Zambia, National Science and Technology Council, Sokoine University of Agriculture, University of Zambia

Country where clinical trial is conducted

Zambia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. At baseline and 8 weeks
Secondary Change in Body weight Weight will be measured using the Seca adult scale At baseline and 8 weeks
Secondary Change of Body Mass Index (BMI) Hand held BMI machine will be used to determine the BMI of each participant. At baseline and 8 weeks
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