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
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Overweight
• Overweight and Obesity

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