Overweight and Obesity in Relation to Type ll Diabetes Melitus

NCT04016012 | Unknown DMC

• 1 other identifier: MU0619
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diabetes Mellitus, Type 2; Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Body weight

  At baseline and 8 weeks

• Change of Body Mass Index (BMI)

  At baseline and 8 weeks

Study Arms (2)

Intervention arm

EXPERIMENTAL

Participants in the intervention group will receive local zambian foods and standard health care for eight (8) weeks.

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.

Interventions

Local Zambian Foods DIETARY_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.

Intervention arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Diabetic patients attending Kitwe Teaching Hospital
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mukuba University: lead
• University of Zambia: collaborator
• Afe Babalola University, Nigeria: collaborator
• Buea University, Cameroon: collaborator
• Sokoine University of Agriculture: collaborator
• Kitwe Teaching Hospital, Zambia: collaborator
• National Science and Technology Council: collaborator

Study Sites (1)

Kitwe Teaching Hospital

Kitwe, Copperbelt, 50100, Zambia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Given Chipili

  Mukuba University, Kitwe, Zambia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Given Chipili

CONTACT

+26097874900; chipiligiven@yahoo.com

Chiza Kumwenda

CONTACT

+260974150967; chiza.kumwenda@unza.zm

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2019
• First Posted: July 11, 2019
• Study Start: April 30, 2023
• Primary Completion: September 30, 2023
• Study Completion: October 15, 2023
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months after the study ends.
• Access Criteria: Mukuba University Website

Locations

ZA (1)